Document baqv4zKoydvkDw16nJGo8KBj0

FILE NAME Talc TALC DATE 1973 DOC TALC075 DOCUMENT DESCRIPTION Petition to the FDA to Regulate Putting Asbestos in Foods & Drugs Lae U.S. FOOD AND DEPARTMENT OF BEFORE THE DRUG ADMINISTRATION HEALTH EDUCATION AND WELFARE CENTER FOR SCIENCE INTEREST and IN THE PUBLIC ENVIRONMENTAL DEFENSE FUND INC Petitioners To Honorable Sherwin Gardner Acting Commissioner Food and Drug Administration PETITION REQUESTING IMMEDIATE PROMULGATION OF REGULATIONS UNDER THE FEDERAL FOOD DRUG AND COSMETIC ACT TO PROHIBIT THE ADULTERATION :- OF FOODS AND DRUGS WITH ASBESTOS TABLE OF CONTENTS I. Petition ee ew ke ww we ee ww we ew el II Authority for the Petitioner . . ' 6 ' ' ' ' ' #' ' III Petitioner's SS IV Related Proceedings a V. The Evidence of Asbestos in Foods and Drugs , : . A. Contamination from Contact with Asbestos Filters s . e e e ea e *. e . e s e . s e e e e B. Contamination from Asbestos in Talc .. + VI The Carcinogenicity and Grave Dangers to Asbestos we ee ee ew ww of Exposure ee ew VII Legal Grounds for Relief . . ee eee ee te ee es The Act Requires the Commissioner Prohibit the Intentional Addition to Foods and Drugs a Immediately of Asbestos A. Foods under Containing Asbestos Are Adulterated Section 402 of the Act a er B. Drugs Containing Asbestos Are Adulterated under Section 501 of the Act we ee ee VIII Previous Requests for Relief . 2. 2 2 e+ e+ 2 se ' ees IX Relief Requested . . 6 + + ' ' ' ' ' ' te ew ee ees X. Prayer for Relief , ew ee ew ee te ee et ee APPENDICES Tab A. B.I. Castleman and Center for Science A.J. Fritsch in the Public Asbestos and You Interest 1973 Tab B. J. Churg et al Biological Effects of Asbestos Appendices omitted presented at the National Institutes of Health February 1 1973 Tab C. TECH FACTS advertisement for Crystal White washed asbestos filter pads discs and sheets Cellulo Company Hoboken New Jersey Tab D. H.J. Wehman and B.A. Plantholt Asbestos Fibrils in Beverages I. Gin Bull Environ Contam & Toxicol in press 1973 Tab E. Tab F. Letter from Harold W. Ballew President Nuclepore Corporation to Dr. S.L. Adams Technical Director Joseph Seagram and Sons Inc. March 15 1973 with attachment Correspondence with FDA officials ii U.S. FOOD AND DEPARTMENT OF BEFORE THE DRUG ADMINISTRATION HEALTH EDUCATION AND WELFARE CENTER FOR SCIENCE INTEREST and IN THE PUBLIC ENVIRONMENTAL DEFENSE FUND INC Petitioners - To Honorable Sherwin Gardner Acting Commissioner Food and Drug Administration I. PETITION REQUESTING IMMEDIATE PROMULGATION OF REGULATIONS UNDER THE FEDERAL FOOD DRUG AND COSMETIC ACT TO PROHIBIT THE ADULTERATION OF FOODS AND DRUGS WITH ASBESTOS This petition involves an imminent and wholly unnecessary hazard to public health This hazard results from the inten- tional addition of carcinogenic asbestos particles to a large number of foods and drugs directly and indirectly either from contact with asbestos filters in the preparation of foods and drugs or from the addition to foods and drugs of talc which often contains asbestos The contamination of foods and drugs with asbestos particles from these sources has been known to the Commis- sioner for several years See pp 19-22 infra The car- cinogenic properties of asbestos in man and test animals have also been well documented for several years See pp 9-13 , infra The existence of practical alternatives to the use of asbestos filters has also been demonstrated See pp 20-21 , infra Because of the extremely grave danger of exposing the entire human population to accumulating doses of a known carcinogen and the ready availability of practical alternatives Petitioners request the Commissioner to adopt the regulations proposed below immediately The FDA has already delayed more than three years in taking such action despite Petitioners frequent requests for relief See pp 19-22 , inf a Since there is no level of exposure to asbestos which is known to be safe any further delay of regulatory action could result in irreparable injury to the public on a massive scale This need for immediate action is made even more urgent by the many other exposures of the general population to asbestos Therefore Petitioners request the Commissioner to exercise his authority under section 701 and other appli- cable provisions of the Federal Food Drug and Cosmetic Act to A. Publish in the Federal Register immediately within 30 days and promulgate as soon as practicable thereafter the following proposed regulations Petitioners Proposed Regulations 1. Subpart F of Part 121 is amended by adding the following section 121 Filters containing asbestos Foods that have come into contact with filters made wholly or partially of asbestos may reasonably be expected to become contaminated with asbestos particles which may be injurious to health when ingested Accord- ingly any food or food additive produced manufactured processed or prepared using a filter made wholly or partially of asbes- tos shall be deemed to be adulterated in violation of section 402 of the Act 2 Part 133 is amended by adding the following sections 133 Filters containing asbestos Drugs passed through filters made wholly or partially of asbestos may reasonably be expected to become contaminated with asbestos particles which may be injurious health when injected or ingested Accordingly any drug or drug component produced manufactured processed or prepared using a filter made wholly or partially of asbestos shall be deemed to be adulterated in violation of section 401 of the Act 133 Talc containing asbestos Talc is a naturally occurring hydrous mag- nesium silicate which may reasonably be expected to be contaminated with asbestos particles As- bestos particles may be injurious to health when ingested or injected Accordingly it is not considered good manufacturing practice to add talc directly or indirectly as a component in the pro- duction manufacture processing or preparation of any drug unless the manufacturer or processor of the drug first demonstrates by appropriate tests that the talc so used is free of asbestos particles Any has drug or drug component containing talc which not been demonstrated to be free of asbestos particles shall be deemed to be adulterated in violation of section 501 of the Act B. Promulgate immediately within 30 days from the receipt of this petition the proposed regulations for estab- lishing a zero tolerance for asbestos particles in talc in- tended for use as a food additive which the Commissioner published in the Federal Register on August 12 1972. 37 Fed Reg 16407-16408 The factual and legal grounds for this petition are set forth more fully within II AUTHORITY FOR THE PETITION The Commissioner has the authority and duty to grant this petition under sections 201 301 402 409 501 and 701 of the Federal Food Drug Cosmetic Act 21 U.S.C. 371 a 321 331 342 348 351 and - Petitioners authority to submit this petition derives in part insofar as it relates to the addition of asbestos to foods from section 409 of the Act 21 U.S.C. 348 ; 21 C.F.R. 121.51 As parties aggrieved by agency action within the meaning of sections 301 and 501 of the Act Peti- tioners have a right to the relief requested from the adulteration of drugs with asbestos See 5 U.S.C. 702 III PETITIONERS 1 Petitioner Center for Science in the Public Interest CSPI is a Washington profit corporation composed of scientists dedicated to public interest research and advo- cacy on public health and environmental issues CSPI's head- quarters are located at 1779 Church Street N.W. Washington D.C. Dr. Albert Fritsch Director of CSPI and Barry Castleman a research associate recently published a report on the uses and dangers of asbestos entitled Asbestos and You a copy of which is appended at Tab A. 2 Petitioner Environmental Defense Fund EDF is a national profit membership organization composed of more than 35,000 scientists lawyers educators and other citizens dedicated to the preservation and wise use of the environment and the protection of public health from envi- ronmental degradation EDF's national headquarters are located in East Setauket New York and its Washington headquarters are located at 1525 18th Street N. W. Washington D. C. IV RELATED PROCEEDINGS 1. On August 12 1972 the Commissioner proposed a regulation that would have established a zero tolerance asbestos particles in talc intended for use as a for food additive 37 Fed Reg 16407 Aug. 12 1972 Final action on this proposed regulation has apparently been postponed indefinitely despite the continued addition of asbestos- contaminated talc to food 2. The FDA claims to have a related investigation in on the contamination of foods and drugs processed progress through asbestos filtering media See letter from Gerald F. Meyer Director Office of Legislative Services FDA to Senator Charles McC Mathias Jr. Oct. 16 1972 Tab F p4 3. The FDA also claims to have a related investigation in progress asbestos in to establish an analytical methodology for detecting talc See letter from Alfred Weissler Ph.D. Acting Director Division of Color and Cosmetics Technology Office of Product Technology FDA to Dr. Lucile Adamson and Scott Lang EDF March 2 1973. Tab F p 22 4. On July 26 1972 the Commissioner banned the use of asbestos in general garments under the Federal Hazardous Sub- stances Control Act 37 Fed Reg 14872 July 26 1972 ~ V. THE EVIDENCE OF ASBESTOS IN FOODS AND DRUGS The presence of asbestos a known carcinogen in foods and drugs is documented The two primary routes of asbes- tos contamination of food and drugs identified thus far are 1 from contact with filters made wholly or partially of asbes- tos and used in the clarifying sterilizing or polishing of a wide variety of foods beverages and drugs and 2 as a natural ingredient of commercial talcs which are sanctioned by the FDA for use in the manufacture and packaging of a vast number of food and drug products A. Asbestos Contamination with Asbestos Filters from Contact Filters made wholly or partially of asbestos may be used in the preparation of virtually all liquid foods bever- ages and drugs which require filtration The attached adver- tisement from the Cellulo Company for Crystal White washed asbestos filter pads discs and sheets lists the following typical applications many of which are for food or drug products acids alkalies antibiotics antiseptics aperitifs beer biotics blood plasma brandies cider condiments coolants . cordials cosmetics creams detergents dextrose solutions disinfectants drinking water electoplating baths essential oils extracts fruit juices gin hair tonics inks insecticides jet fuels lotions mouth washes perfumes oils pharmaceuticals photographic solutions saline solutions serums shampoos shel- lac soaps soft drinks syrups tonics vaccines vinegar vodka whiskies wines The presence of asbestos particles in liquids filtered through asbestos filters has been confirmed by a number of studies As early as 1969 Nicholson and workers found that asbestos filters contaminated drug solutions used in intravenous intramuscular and intraperitoneal injections and reported this to the FDA W.J. Nicholson C.J. Maggiore and I.J. Selikoff Asbestos Contamination of Parenteral Drugs Science Vol 177 pp 171-173 July 14 1972 Recently Dr. H. J. Wehman and B. Plantholt reported the presence of asbestos particles in samples of commercially retailed gin filtered through asbestos filters H. J. Wehman and B.A. Plantholt Asbestos Fibrils in Beverages I. Gin Bull Env Contam Toxicol in press Tab D Dr. Wehman and Ms. Plantholt have also discovered the existence of asbestos particles in commercially retailed beer See inter- office correspondence from B. Castleman and V. Gambill to T.H. Devlin Sept. 28 1972 Tab F pp 9-11 B. Contamination from Asbestos in Talc Talc which has no inherent nutritional or medicinal value is used in the preparation of a wide variety of food and drug ient products and filler For for example talc is commonly used pills and tablets for dusting as an exciptablet molds in clarifying liquids by filtration in salami dusting candy molding in peanut polishing in the coating of polished rice in paper and paperboard and cotton and cotton fabrics used in dry food packaging as a chewing gum base and as an antisticking agent in forms used for molding various food shapes See FDA Proposal Regarding Regulation of Prior Sanctioned Food Ingredient3s7 Fed Reg 16407 at 16408 August 12 1972 The Merck Index An Encyclopedia of Chemicals and Drugs 8th edition Merck and Co. 1968 p 1011 Mineral Facts and Problems U.S. Dept. of the Interior 1970 pp 853 1272 The naturally occurring presence of asbestos particles in talc has been confirmed by a number of studies Cralley and his workers noted the presence of fibers in most of the cosmetic talcum powders they studied in 1968 L. J. Cralley M. M. Key O. H. Croth W. S. Lainhart and R. M. Lingo 29 J. Amer Ind Hyg Assoc 350 1968 More recent studies by Dr. Arthur Langer at Mount Sinai Hospital in New York reportedly have confirmed this observation and identified the asbestos particles present Studies by Dr. Seymour Lewin at New York University under contract for the Food and Drug Administration but still unreleased have also reportedly shown that a significant percentage of talcum products sampled contained quantities of asbestos See letter from Dr. Weissler to Dr. Adamson and Mr. Lang March 2 1973 supra Any of the uses of talc listed above therefore may cause food or drugs to be contaminated with asbestos For example it has been reported that rice treated with talc as a polishing agent contains asbestos fibers even after having been washed and cooked R. Rice and Japanese Cancer R. Merliss Treated Science Vol 173 p 1141 1971 See also Science Vol 175 p 474 1971 The Commissioner of course has acknowledged the presence of asbestos in talc intended for use as a food additive and ten months ago pro- posed to prohibit use of such talcs in food Thus far however he has taken no final action 37 Fed Reg 16407 Aug. 12 1972 VI THE CARCINOGENICITY AND GRAVE DANGERS _ OF EXPOSURE TO ASBESTOS A growing body of epidemiological data case studies and animal experiments has established a definite relationship between exposure to asbestos and lung cancer gastrointestinal cancer and mesothelioma a rare cancer of either the pleura the membrane encasing the lungs or the peritoneum the lining of the abdomi- nal cavity See Tabs A and B The most startling evidence of asbestos carcinogenicity has come from the epidemiological studies of asbestos insulation workers conducted by Dr. Irving J. Selikoff and workers at the Mount Sinai School of Medicine in New York These studies establish that about 40 percent of the deaths among asbestos workers are due to cancer About one in every five deaths are due to lung cancer about one in ten to gastrointestinal cancer and about one in ten to pleural or peritoneal mesothelioma Ibid Asbestos cancers usually do not develop until 20 to 30 years after initial exposure Once thought to be limited to heavily exposed asbestos workers these neoplasms are now known to result from exposure to very low levels for relatively brief periods For example mesothelioma a malignancy which is ex- tremely rare in the general population has frequently been found among those living in the household of asbestos workers tT eS ranices Ree those working in shipyards where asbestos is used in some areas or those living in the vicinity of asbestos manufacturing and fabrication operations See Nicholoson et al Asbestos Contamination of Parenteral Drugs supra p 171 n 5-8 A safe level of exposure below which there is no increased risk to health has not been established Therefore given present knowledge and the extremely serious consequences asbestos- caused disease the only measure available to protect public health is to eliminate exposure to asbestos to the greatest degree possible from all sources The Commissioner in proposing to establish a zero tolerance for asbestos fibers in talc intended for use as a food additive acknowledged not only the carcinogenic proper- er mee tn ties of asbestos when inhaled but also the increased potential me for cancer when asbestos is ingested 37 Fed Reg 16408 The me evidence that asbestos is carcinogenic in man when ingested or ee injected is far from speculative Selikoff et al have con- sistently reported cancer of the esophagus stomach colon and rectum in asbestos workers at about two or three times the rate expected in spitoef the enormous competing risks from other as- related cancers and from asbestosis Tab B pp 10- 14 A similar excess has been found among asbestos insulation workers in Belfast P. C. Elmes and J. C. Simpson Insulation Workers in Belfast Mortality 1940-1966 Brit J. Industr Med Vol 28 pp 226-236 1971 Whether increased gastrointestinal cancer occurs as the result of swallowing airborne asbestos or from other environ- mental exposure has not been studied Selikoff et al specu- late that part and throat and of inhaled swallowed asbestos may or it may be be returned to the mouth carried into the mouth by -10- contaminated food on fingers But they also observe that There may be opportunity for asbestos contamination through contamination of food and fluids filtration through asbestos filters flow through asbestos cement pipes talc as food additive The significance of these observations is not . known Tab B p 10 Although in the limited studies to date no_excess of tumors has been observed in the gastrointestinal tract of ani- mals fed asbestos other animal tests have confirmed the carci- nogenic properties of asbestos Cancer has been reported in test animals after receiving intrapleural intraperitoneal and subcutaneous injections of asbestos fibers See Asbestos - The Need for and Feasibility of Air Pollution Controls National Academy of Sciences Washington D. C. 1971 p 7 n 138 159 160 Mesothelioma has also been induced by subcutaneous injections in mice indicating the migration of fibers to the pleura and peritoneum once inside the body Ibid p 7 n 123 Although the numbers of fibers introduced in these tests were too large to be translated directly into human experience with any certainty the animal data establish the strong potential for cancer in man through either ingestion or injection of foods or drugs containing asbestos Asbestos is not merely an occupational hazard limited to certain industrial workers Since the turn of the century the United States has increased its consumption of asbestos from a few thousand tons per year to nearly a million tons per year at present Tiny asbestos fibers have become virtually ubiqui- tous Urban air is almost always contaminated with asbestos fibers from construction and demolition operations from the wear on asbestos brake linings and from other common sources -11- Random autopsies have revealed the presence of tiny asbestos fibrils in the lungs of virtually all urban dwellers examined and in about half of those examined small fibrous lumps called asbestos bodies were also observed A. M. Langer I. J. Selikoff A. Sastre Arch Environ Health Vol 22 p 348 1971 Consumer products are another important source of asbestos exposure Talcum powders ironing boards drapes blankets coats gloves plaster wallboard papermache are only a few of the household items Tab A pp 32-35 50-53 that contain asbestos fibers Asbestos fibers in food and drugs therefore contribute to the cumulative exposure of the public Little is known about the effects of such prolonged level exposure But the long latency period between exposure and manifestation of the various malignancies often 30 years or more could allow these dangers to go unnoticed for years before a public health crisis becomes fully evident Millions of Americans may already have received a critical dose of asbestos fibers not merely through the air they breathe but through their food and drugs The seriousness of the consequences and the absence of a known safe level make it imperative therefore that human exposure from all known sources be reduced to a practical minimum Other federal agencies have taken important steps toward reducing asbestos exposure The Occupational Safety and Health Administration recently promulgated standards for occupational exposure to asbestos dust 37 Fed Reg 11318 June 7 1972 The Environmental Protection Agency has declared asbestos a hazardous air pollutant pursuant to section 112 of the Clean Air Act of 1970 42 U.S.C. 1857c and has issued regulations requiring the elimination of visible emissions to the atmosphere 38 Fed Reg 8820 et seq April 6 1973 The Commissioner * ~ Recently asbestos in significantly high concentrations was discovered in the water supply of Duluth Minnesota as a result of contaminated mine tailings dumped nearby into Lake Superior by the Reserve Mining Company An emergency study is now in progress by EPA under court order to deter- mine whether this city of 100,000 inhabitants must develop a new water supply free of asbestos because of the potential cancer risk -12- himself has declared asbestos in general garments illegal and has proposed to establish a zero tolerance for asbestos fibers in talc added to food The Commissioner however has delayed more than ten months tos in in promulgating talc additives the proposed zero tolerances for asbes- And he has neglected despite the re- peated requests of Petitioners and others to expand the scope of this regulatory action to eliminate talc containing asbestos from drugs and the use of asbestos filters in the preparation of both foods and drugs Given the substantial evidence of asbestos carcinogenicity and the widespread contamination of food and drugs with asbestos fibers and fibrils any further delay of effective regulation only increases the already sub- stantial risk to public health VII LEGAL GROUNDS FOR RELIEF The Act Requires the Commissioner Prohibit the Intentional Addition Foods and Drugs to of Immediately Asbestos to The central purpose of the Federal Food Drug and Cos- metic Act is to assure that consumers will not be exposed to poisonous or or in drugs deleterious substances devices or cosmetics through their food supply Thus section 301 of the Act makes it illegal to introduce into interstate commerce any food drug device 21 U.S.C. 331. And or cosmetic that is adulterated or misbranded section 701 of the Act grants the Commis- sioner authority to promulgate regulations for the efficient enforcement of this Act " 21 U.S.C. 371 a The strict enforcement of the Act by the Commissioner is the public's -13- only means of defense against hidden hazards to health from impurities such as asbestos A. Foods Under Containing Asbestos Are Adulterated Section 402 of the Act Under section 402 of the Act as amended a food shall be deemed to be adulterated or a 1 If deleterious it bears or contains substances which may jurious to health ; or any poisonous render it in- food 2 C if it is or bears or contains any additive which is unsafe within the meaning of section 409 ; or 3 if it consists in whole or in part any filthy putrid or decomposed substance if it is otherwise unfit for food or of or held 4 if it has been prepared packed or under insanitary conditions whereby it may have become contaminated with filth or whereby it may a have been rendered injurious to health 21 U.S.C. 342 a 1 emphasis added ] Sufficient evidence has been supplied by Petitioners and others to establish that the contamination of foods with asbestos a proven carcinogen renders them adulterated within the meaning of the quoted language The evi- dence set forth by Petitioners more than adequately supports their contention that the presence of asbestos in food may be injurious to health and is unfit for food Moreover asbestos which enters food products indirectly via talc tive as or from contact with asbestos filters is a food * defined by section 201 of the Act Therefore addiit is */ A food additive defined by the Act to include any substance the intended use of which results or may reasonably be expected to result directly or indirectly in its becoming a component or otherwise affecting the characteristics of any ] food .. . 21 U.S.C. 321 emphasis added -14- subject to regulation under section 409 of the Act govern* ing food additives 21 U.S.C. 348 See 21 C.F.R. 121.1 Section 40 39 A of the Act provides in relevant part That no be safe food additive shall be if it is found to induce deemed cancer to when ingested by after tests man or animal or if it is found which are appropriate for the evaluation of the safety of food additives to induce cancer in man or animal .- 21 U.S.C. 348 c 3 A The evidence set forth above documenting the carcino- genicity of asbestos in humans and animals including increased cancers in humans is sufficient to meet the gastrointestinal requirements of section 409 c 3 A Therefore the Commis- sioner is required to prohibit immediately any intentional direct or indirect addition of asbestos to foods at least until such time as it has been conclusively shown that asbes- tos is not carcinogenic when ingested The need for immediate action is accentuated when consideration is given to the other exposures of the public to asbestos B. Drugs Containing Asbestos Are Adulterated Under Section 501 of the Act Section 501 of the Act states in relevant part that A drug or device shall be deemed to be adulterated -- * ~ Although talc is now exempted from the food additive regulation because it is on the list of substances generally recognized as safe GRAS and has a prior sanction from the FDA under 21 C.F.R. 121.101 and i and 21 C.F.R. 15.525 these prior sanctions and GRAS listing apply only to talc they do not apply to the asbestos in talc which is also an additive Additionally since new scientific information confirms the carcinogenicity of asbestos the natural occurrence of asbestos in talc and the presence of asbestos in food to which talc has been added the prior sanctions and GRAS listing for talc should have been rendered invalid since contaminated talc may be injurious to health See 21 C.F.R. 121.2000 b hardly dis- and C.F.R. 121.3 The Commissioner can since he has found that talc contaminated with agree asbestos may be injurious to health when ingested and has proposed to eliminate its prior sanction and GRAS listing See 37 Fed Reg 16408 supra -15- a If it consists in whole or in part of any filthy putrid or decomposed sub- stance or 2 A if it has been prepared packed or held whereby it may under insanitary conditions have been contaminated with filth or whereby it may have been rendered injurious to health and the methods used or in B or if it is a drug the facilities or controls used for its manufacture pro- cessing packing or holding do not conform to or are not operated or administered in conformity with good manufacturing practice to assure that such drug meets the require- ments of this Act as to safety . 21 U.S.C. 351 2 emphasis added Petitioners contend that any drug containing asbestos as a result of either the use of asbestos filters or asbestos- containing talc meets the definition of adulteration set forth above The evidence of the health hazards of asbestos in man and test animals more than adequately supports the contention that the presence of asbestos particles in drugs may be injurious to health Ingested drugs are no different in this respect than foods contaminated with asbestos and for the same reasons of safety should be required to be free of asbes- tos Injected or parenteral drugs containing asbestos may be even more hazardous since experimental animal data show that asbestos fibers can migrate through the blood and lymph systems when injected resulting in pleural and peritoneal mesothelioma See p 11 supra Therefore any drug prepared using asbestos filters or to which containing talc has been added should be deemed adulterated and these practices should be prohibited at once Present methods of drug processing which use asbestos filtering media or add talcs containing asbestos are also in violation of the FDA's Regulations Prescribing Current Good Manufacturing Practice in the Manufacture Processing Packing or Holding of Drugs 21 C.F.R. 133.4 133.6 -16- part Section 133.4 of those regulations states in relevant The equipment shall a Be so that come constructed that all surfaces into contact with a drug pro- duct shall not be reactive additive or absorptive so as to alter the safety identity strength quality or purity of the drug or its components beyond the official or other established requirements Emphasis added] Since the use of asbestos filters is adulterating drugs within the meaning of section 50 21 A of the Act and is in violation of the quoted regulation because it is a process which is additive to drugs so as to alter their safety beyond established requirements the Commissioner is required to prohibit the use of such filtering media in the processing of drugs Any further delay by the Commissioner in promulgating regulations to prohibit such practice is in- excusable since adequate filter substitutes exist which con- tain no asbestos Furthermore at least one manufacturer claims to produce a filter which can remove asbestos fibers and fibrils from aqueous solutions See letter of Harold W. Ballew President Nuclepore Corp. to Dr. S. L. Adams Tech- nical Director Joseph E. Seagram and Sons Inc. March 15 1973 Tab E Although the removal efficiency of this filter for other substances is less than 100 its use downstream of an containing filter is an alter- native which could be permitted in special cases where adequate substitutes for the asbestos filter do not exist -17- Section 133.6 of Part 21 of the Code of Federal Regu- lations states in relevant part 133.6 Components . Components shall be withheld from use until they have been identified sampled and tested for conformity with established specifications and are released by a materials approval unit * * * c Representative samples of components liable to contamination with filth insect infestation or other extraneous contaminants shall be appropriately examined Emphasis added] Talc is a component of many drugs See p 7 supra Since asbestos is a natural contaminant of talc section 133.6 c requires representative samples of talc to be tested appropriately for asbestos Appropriate testing of talc for asbestos despite Petitioners repeated requests see infra pp 19-22 ) has not been required of drug manufacturers Petitioners contend that unless and until the Commissioner requires such appropriate tests to assure that talc is asbestos all drugs to which talc is added should be deemed to be adulterated and prohibited from interstate commerce The burden of demonstrating that a component of a drug is not contaminated lies with the producer not with the public or the Commissioner -18- VIII PREVIOUS REQUESTS FOR RELIEF The fact that asbestos is a natural contaminant of commercial talc has been common knowledge for years The presence of asbestos fibers in liquids filtered through asbestos was made known to the FDA as Nicholson and workers at the Mount early Sinai as 1969 by Dr. School of Medi- cine when they first discovered asbestos in parenteral drugs Thus for at least three years the Commissioner has known that asbestos a proven carcinogen is present in talcs used in foods and drugs and in liquids purified through asbestos filters but he has taken no regulatory action During this time Petitioners have repeatedly requested the FDA to take the necessary steps to eliminate this serious risk to health However all of Petitioners inquiries about whether the FDA is taking such action have been frustrated by delay false promises obfuscation and lately silence For example on July 7 1972 Mr. Barry Castleman of CSPI petitioned the FDA to perform analyses of beverages etc. for contamination by asbestos in filters in food and drug processing See letter from Barry Castleman to Dr. John M. Gowdy FDA July 7 1972 Tab F pp 1-2 Dr. Gowdy replied that the FDA had been doing analyses for asbestos during the past year and stated that As an incidental result of this activity we believe the use of asbes- tos filters is being discontinued See letter from Dr. John M. Gowdy FDA to Barry Castleman July 12 1972 Tab F p 3 : -19- A few months later Gerald F. Meyer Director of the Office of Legislative Affairs FDA stated to Senator Charles McC Mathias Jr. who had made an inquiry to FDA on behalf of Mr. Castleman the FDA had an investigation of asbestos filters in progress and assured Senator Mathias that If of of these investigations reveal hazardous materials in food the use of asbestos filters the presence as a result or any other food contact material all necessary measures provided for in the law will be undertaken protect the public's health Letter from Gerald F. Meyer FDA to Senator Charles McC Mathias Jr. October 16 1972. Tab to Fp 4 On October 24 1972 Mr. Castleman wrote to the FDA requesting a description of the scope and methods of the study the FDA claimed to have in progress Letter from Barry Castleman to Gerald F. Meyer FDA October 24 1972 Tab F p 5 This information however has never been supplied On December 5 1972 Mr. Castleman wrote to Senator Mathias again He informed him that in September of 1972 he had in his capacity as a public health official for the State of Maryland inspected a brewery and a distillery in Baltimore County and found that each plant was using asbes- tos filtering media contrary to the FDA's belief that they were being discontinued Subsequent analysis for asbestos by Dr. H. Wehman electron microscopist proved positive in both products whereas the analysis was negative for pre- filter beer and metropolitan water samples Upon learning of the hazards of asbestos filters the brewery voluntarily replaced them with asbestos substitutes See letter from -20- B. Castleman to Senator Mathias Dec. 5 1972 Tab pp 6-11 The results of this study were forwarded to the FDA through Senator Mathias As Petitioner Castleman pointed out The food industry's potential for voluntary compliance substitution by asbestos filters if requested and the simplicity of demonstrating the presence of this carcinogenic food additive have been demonstrated in the Baltimore County study I hope direct we can get the FDA to take a more approach to protect the public's health Ibid On January 2 1973 Pat T. Adamo Office of Compliance Bureau of Foods FDA wrote Mr. Castleman that a meeting with food and asbestos industry representatives was being held to discuss the use of any types or forms of asbestos in food processing applications He stated that the FDA had requested details of asbestos use including data as to the amount of asbestos fibers present in their products and steps taken to assure the absence of asbestos in the final con- sumer product They should also consider what they could use as a replacement . - Letter from Pat T. Adamo FDA to B. Castleman January 2 1973. Tab F p 13 Apparently a real investigation had not been conducted previously Unfortunately Mr. Castleman to attend the this letter was mailed meeting and appears to too late for have been one more in a long series of attempts by the FDA to give what Mr. Castleman has labeled just the old runaround See letter from B. Castleman to Senator Mathias January 5 1973 Tab F pp 14-15 On February 26 1973 Mr. George F. Meyer FDA wrote again to Senator Mathias about the FDA's progress in investi- gating the use of asbestos filters in the food and drug indus- ~ tries -21- We have not compiled any listing such as requested by Mr. Castleman of the types of asbestos filters which may be used in the food industry Industry little data has advised us that they have available on how much asbestos is removed during filters are used processing ... when asbestos Most ology feel that reliable and is control tool of the experts of methodelectron microscopy is not very difficult to use as As Mr. Castleman can appreciate it would be useless to regulate the levels of a sub- stance in food if adequate methodology is not available to determine any violations that may occur .. . Letter from Gerald F. Meyer to Senator Mathias February 26 1973 Tab F pp 17-18 * In short after two years of investigation the FDA has made almost no progress in eliminating this very serious risk to public health nor is there any reason to believe that the FDA has taken any for relief since this further action on Petitioners last communication of February requests ** 26 1973_ * In answer to the point raised by Mr. Meyer in the 4th para- graph quoted above it should be noted that Petitioners are not requesting that the FDA regulate the levels of asbes- tos added to food and drugs Petitioners are requesting that such additions be prohibited No complicated method- ology would be required to determine whether or not asbestos filters or talc were being used in the production of foods or drugs This determination would be made by simple pro- cess inspection We can only regard Mr. Meyer's citation of the difficulties of electron microscopy as a control tool as an indication that the FDA would like to allow a certain level of asbestos to be added to food if only they had the ability to monitor that level Such an asbestos tolerance would be unacceptable and contrary to law The processes by which asbestos is added should not be controlled but eliminated with the concurrent elimination of any routine need for using electron microscopy as a con- trol tool ** Petitioner EDF has experienced similar frustration in its attempts to find out the status of FDA investigations of asbestos in food and drugs EDF wrote to the Director of the Bureau of Drugs in FDA on December 14 1972 and again on April 11 1973 inquiring whether FDA is taking action to insure the exclusion of asbestos from parenteral drugs As of this date Petitioner EDF has still not received a response See letters from Dr. Lucile F. Adamson and Scott H. Lang EDF to Dr. Henry Simmons Director Bureau of Drugs FDA, December 14 1972 and April 11 _* 1973 Tab F pp 20- 21 -22- IX RELIEF REQUESTED Because of the grave dangers resulting from exposure to asbestos 1. Petitioners request that the Commissioner immediately or within 30 days publish in the Federal Register the proposed regulations set forth above prohibiting the intentional addition of asbestos to foods and drugs and promulgate final regulations as soon as practicable thereafter 2 Petitioners request that the Commissioner immediately or within 30 days promulgate the proposed regulations for estab- lishing a zero tolerance for asbestos particles in talc intended for use as a food additive which he published in the Federal Register on August 12 1972. 37 Fed Reg 16407-16408 3. Take whatever other action he deems necessary to eliminate contamination of foods and drugs with asbestos X. PRAYER FOR RELIEF For the reasons set out the Petitioners request that the Commissioner grant the relief requested in this Petition Respectfully submitted June 27 1973 Scott H. Lang Attorney for Petitioners 1525 18th Street Washington D. C. 202 833-1484 N.W. 20036 -23-