Document rb8rLan3zjkDN0yELEp666bq

FILE NAME Talc TALC DATE 1973 DOC TALC081 DOCUMENT DESCRIPTION Federal Register Notice a -- PROPOSED RULES the ent procedures otherwise summary - provided ent shall inform the affected ~ employees and official in charge the being injured establishment of the danger and require sent . immediate abatement including with drawal of employees from appropriate -.. circumstances the dangerous ment and a of steps being 133 Filters containing asbestos taken in the interim em- ployees from injured the haz- Drugs passed or partially of through filters made wholly ard A copy of the will be asbestos may reasonably be to expected to become the safety and health committee of the with contaminated asbestos particles which may be injurious to agency for comment The health when injected or ingested Accord- head of each agency will inform the Sec- ingly any drug or drug component produced hazards 1960.26 Notices of retary of Labor regular intervals to a Each agency will establish a pro- be determined by the Secretary as to the cedure for issuing notices of hazards dis- progress made in carrying out the abate- ~ ment plan Any changes in the abate- manufactured processed or prepared using a filter made wholly or partially of asbestos shall be deemed to be adulterated in viola- tion of section 401 a of the Act - covered upon inspection Notices will de- _ scribe with particularity the nature - of the hazard including a reference to the standard or other requirement involved The notice will also fix a reasonable time for the abatement of the hazard A ment plan will require the submission of a new plan in accordance with the pro- visions of this section ; Subpart Federal Agency Internal Evaluation $ .___ Talc containing asbestos Talc is a naturally occurring hydrous magnesium silicate which may reasonably be expected to be contaminated with asbestos particles Asbestos particles may be injurious to health when ingested or injected Accord- notificattioon - Office hazard copy of the notice will be sent to the 1960.28 Duties of Federal agencies ingly it is not considered good manufactur- official in charge of the establishment ing practice to add talc directly or indirectly b If a notice of hazard is issued as Each agency shall conduct an annual as a component in the production manu- a result of a request for inspection under detailed internal evaluation of its occu- facture processing or preparation of any 1960.24 or notification of hazard pational safety and health program Basic drug unless the manufacturer or processor under 1960.24 a copy of the notice guidelines for this evaluation will be is- of the drug first demonstrates by appropriate tests that the _ * of hazard will also be sent the em- sued periodically by the Office of Federal talc so used is free of asbestos particles ployee or representative of employees Agency Safety Programs internal Any drug or drug component containing talc which has not been who made such request or evaluations shall be utilized by each demonstrated to be free of asbestos particles ( receipt of any notice of haz- a_ papgleinccaybfloer stthaetuptuerspaosneds Esxeetcufotritvhe iOnrdtehre sthiaolnl obfesedcetieomne5 d 0to1beofatdhueltAecrtated in viola- ' Ushment charge of an estab- . No. 11612 as described in 1960.1 and ' immediately post such no- Petitioners also request that the Com- shall be maintained and made available | misioner tice a c thereof unedited at or by each agency for review by the missioner immediately within 30 days of , near each place referred in from the receipt of this petition petition petition the notice occurred except Federal as provided Agency Safety Programs promulgate as regulation a zero Washington D.C. below Where because of the nature of - . Signed at .. the establishment operations it is not day September 1973 - ae this 24th coy -. practicable to post the notiac t oer nearLob JOHN STENDER _ each place of hazard notice will be Assistant Secretary of Labor . ' . posted unedited in a prominent place wheitrwiell be readily observable by all FR Doc.73-20707 Filed 9-27-78 am . affected employees For example where ~ establishment activities are physically dispersed the notice may be posted at the location to which employees report OF DEPARTMENT HEALTH EDUCATION AND WELFARE | \ | tolerance for asbestos particles te intended for use food additive a suant to the proposal published in , FEDERAL REGISTER REGISTER August August other FR 16107 and take whatever no- en. necessary tion the Commissioner decins necsary to eliminate contamination drugs with asbestos : of foodand petition A complete copy of the and | attachments may be reviewed office each day Where employees do not pri- marily work at or report single location the notice may be posted at the location from which the employees operate to carry out their activities The of- Food and Drug Administration ~ [ 21 CFR Parts 121 128 133 ] ASBESTOS PARTICLES IN FOOD . AND DRUGS OO. _ of the Hearing Clerk Food and Drug Administration Rm 6-86 5600 Fishers Lane Rockville MD 20852 during work| ing hours Monday through Friday The Commissioner has carefully re- ficial in charge of an establishment will N. otice of Proposed Rulemaking viewed the petition its attachments and . has take steps to ensure that the notice is not other available information and | The Commissioner of Food and Drugs altered defaced or covered by other has received reached the following conclusions Each =. a - aa a petition from the Center conclusion indicates the source reference {i * material copy for Science the Public Interest 1779 _ upon which the conclusion is based and of d Each notice hazard or a copy Church Street NW Washington D.C. copies of all referenced material are * thereof will remain posted until the haz- 20036 and the Environmental Defense available from the office of the Hearing ard has been abated or for 3 working Fund 1525 18th Street NW Washing- Clerk days whichever later ton D.C. 20036 requesting promulgation Le Asbestos is a generic term for num- | - 1960.27 Correction of hazards Food of regulations under the Federal ' ber of hydrated silicates that when a The procedures for correcting haz- Drug and Cosmetic Act to prohibit the crushed or processed separate into flext- ards will include reinspection by the of- adulteration of food and drugs with as- . ble fibers made up of fibrils Although of fice the designated safety health bostos Petitioners request that the Com- there are many asbestos minerals only official to determine whether the correc- missioner publish in the FEDERAL REGIS- six are of commercial importance tion was made If upon reinspection the correction was not made the designated Chrysotile a tubular serpentine mineral , TER immediately within 30 days the - accounts for 95 percent of the world's * - safety and health official shall make this following proposed regulations | | . production The others all amphiboles known fact to the head of the agency for 1. Subpart of Part 121 is amended by adding the following section crystals with 3 groups of metal ions are amosite crocidolite anthophyllite trem- head _ appropriate action desig- olite and actinolite These sbestos b If in the judgment of the desig- 121 Filters containing asbestos minerals differ in their metallic cle- nated safety and health official abate- ..- Poods that have como into contact with mental content range of fiber diameters ment ofa safety or health hazard will atters made wholly partially of asbestos flexibility harshness tensile strengthstrength not be possible within 30 working days - may reasonably be expected to become con- surface properties other attributes . the official charge of the establish- taminated with asbestos particles which may that determine their industrial uses niid ment will submit an abatement plan to injurious tohealth when ingested Ac- cordingly any food or food additive which may affect their respirability dep- 2. . the designated safety and health official produced with a copy thereof to the head of the manufactured processed or prepared using osition retention trtr:anslocation and _ eT agency and to Secretary of Labor a filter made wholly or partially of asbestos be biologic reactivity Ref 1 the floor- bes Such plan will contain an explanation of ; shofalslectiodnee40m2edaboe f tahdeulAtecrtate|: d in violation . Many products such as cement * the circumstances of the delay in abate- ~ 3. Part 138 is amended by adding the fol- ing shingles pipes filters textiles etc. rege ment a proposed timetable for the abate- lowing sections -~ contain asbestos of one kind or another - : FEDERAL REGISTER VOL 38 NO FRIDAY SEPTEMBER 28 1973 0 > PROPOSED RULES are Tate great variations among such oduets oduets with respect to the chances of er release during the use of the prod The likelihood of such fiber release predominantly on the case with abers can dislodged and on to which the use of the prod- destroys the fibers Almost all na- bigs ber used in the United States manufacturing products becomes tightly bound within the products and ally undergoes little actual abrasion wear before being discarded Asbestos products accounting for most of eshestos used in the United States Almales and floor tiles are in this cate- pory Some containing products linings as brake are subjected to real friction their rate of wear is con- derable and at times they are almost completely worn away In the case of brake linings the application of force is so intense and the heat created so great that most chrysotile fibers are destroyed by being converted into another sub- stance which is fibrous NevertheIrsa an appreciable percentage to 3 rent remains as fibrous asbestos and fiber release from products such as asbestos cloth paper and sprayed fire- frofing froofing materials is a serious source of #mision This usually occurs in densely rates mesothelioma mesothelioma mesothelmesotheilioma oma occur at greater mesothelioma persons not so occupationally fold exposed There is a 6 to increase in lung cancer in asbestos workers which is noted as early as 10 to 14 years after significant onset of exposure and is at 20 years Refs through 15 Seven per- cent of deaths in asbestos workers are caused by pleural and peritoneal meso- thelioma Refs 16 through 33 This is marked increase since this tumor is ex- tremely rare in the general population There is suggestive evidence concerning . fur increase in the rate of gastrointesti- mal malignancies in asbestos workers There Ref 34 . is considerable evidence that most human lungs harbor thousands or millions of asbestos fibers although most people do not have asbestosis Refs 35 through 37 This is due to the ubiquity of the substance Some of these fibers are chrysotile asbestos and amphiboles are probably present also This number of fibers is relatively small in most persons not occupationally exposed to asbestos compared with the numbers found in the occupationally exposed The systematic application of quantitative techniques measuring both coated and uncoated fibers is needed to define a gradient of accumulated fibers for correction with incidence of disease on the one hand were totally cleared by that tract in 48 hours was detected the and annul gastrointes- no no end of week of the rat semed barrier to penetration E. In a published study W. by Smith maintained et al Itef .41 hamsters maintained on a diet of 1 percent chrysotile or through life had no gastrointestinal tumors A report by Westlake Smith itef 42 indicates Splet and indicates that the rat colonic mucosa is penetrated penetrated by chiyso- tile after feeding a diet diet containing 5 per- cent asbestos for 3 months Cunningham and Pontefract Pontefract Ref 43 and 44 injected chrysotile fibers 9.4 and 94 x 10 directly into stomachs of rats Fibers were found in blood and 2-4 other organs days after treatment Control rats although having no asbes- tos in blood also had high levels of asbestos in tissues These workers found that whereas the tap water in Ottawa having a filter plant contained about 2 million fibers per liter the quality of fibers in soft drinks and alcoholic beverages purchased the Ottawa area ranged from 1 to 12 million fibers per liter Even with the technical problems of methodology this seems to indicate that in some beverages correlation fibers and history of environmental exposure the asbestos content may be about the i i 5 cement the other correlation correlation same as in water whereas in others it Solid asbestos . wastes produced during manu- The methodology for quantification of may be increased Thus it is reasonable i facture of containing products asbestos fibers of varying sizes is such to conclude that water and many other use such products and demolition that the results obtained in one labora- beverages for human consumption con- ' can be emission sources These waste ma- tory may vary substantially from those tain substantial amounts of asbestos 2 tarials are disposed of without in another An agency govern- usually regard to potential as emission mental task force together with other There is some evidence that asbestos ces Alternate methods of disposal scientists working in this field is cur- otten resulitn commingling of asbestos- rently attempting to develop aplied standard Containing wastes with municipal wastes technology which can be applied to the open dumps and thus create a long- identification and qualification of asbes: may remove some asbestos mate- filters rial In preliminary preliminary experiment per- ' formed by the Food and Drug Adminis- tration asbestos was added to distilled emission emission source : tos fibers The Environmental Protection _ water and dispersed evenly by the action - ilbers thus ubiquitous in Agency is currently investigating four of an ultrasonic generator and a large percentage of the separate techniques in order to establish - microscopy of this material The amount of this ma- the best method for identification quan- showed large numbers of asbestos Electron which additionally is added to the environment and to food and drugs by > the use asbestos filters is not known tification sizing and typing of asbestos This material particles and fibers At present the Na- an asbestos tional Institute for Occupational Safety Therefore it is obvious that the presence and Health NIOSH recommendass a rial showed pet : 7. of asbestos in these products is only one technique for sampling of air a method :: small source of exposure based on counting fibers greater than 5 Nicholson and his colleagues BS Asbestos inhalation has been known to microns in length using phase contrast be an occupational hazard in workers in illumination at 430x magnification with asbestos mines The asbestos is inhaled a 4 millimeter objective Refs 38 and - Based on their report a study was under- priesthee and lodges in the lungs causing the de- 39 This technique is currently recom- taken by the Food and Drug Administra- velopment of a fibrotic disease known as mended for liquid materials until more tion concerning contamination of par- Arvid asbestosis Asbestosis or abestotic accurate and sensitive practical methods enteral drugs with asbestos Although the . pneumonoconiosis was the first clearly are developed However as indicated be- data are still preliminary the following demonstrated adverse effect of asbestos low another method is proposed for observations are pertinent Parenteral in man It is characterized by a pattern analysis of asbestos fibers in a material drug samples were collected from a num- of roentgenographic changes in the lung such as tale ber of firms Based on phase contrast consistent with diffuse interstitial fi- The evidence concerning the possible microscopy 11 of 13 samples had clear- brosis of variable degree and at times hazard from ingestion of asbestos par- cut evidence of the presence of asbestos . with fibrosis and calcification of the ticles is contradictory and inconclusive one sample was questionably positive pleura clinical changes that include fine rales finger clubbing and shortness of breath each of which may be absent in In an unpublished study by L. M. Swinburn Ref 40 asbestos particles were fed once a week to SPF Wistar rats and one was negative The number of fibers ranged from 2 to 27 the positive specimens of variable sample size Using an individual case and physiologic for 16 and 18 weeks The material was electron microscopy 12 of the 12 samples changes consistent with a restrictive lung administered in butter Although the par- disorder Refs 2 through 8 ticles were of the size range known to In these workers in asbestos mines - malignancies of the lung and of the body produce tumors by other modes of administration no tumorgenic effect was lining tissues namely lung cancer and noted With a single large dose the fibers FEDERAL REGISTER VOL 38 NO FRIDAY SEPTEMBER 28 1973 ae AIR fee Fan a PE SRS eat cars nteaT ad Reagihem crepsn Wo sag eneHE A IVETE nae as eS te Re Gh TES etepsigleis WS Ie ne tate a PROPOSED RULES 27078 W. B. Pulmonary Asbestosis A and occasionally to brain tissue asbestos may enter 8. Soper report of a case and a review 571-584 1930 Am Rev. by followed final membrane type filters kidneys that some asbestos filters for its suggesting Tu9b. eLrycnch K. M. and W. A. Smith Pul- one of these uses final filtration of the circulation evidence monary Asbestosis III Carcinoma of lung in experimental water without Thus there is Am J. Cancer 56-64 asbestos such water and two firms use that parenteral administration of asbes- silicosis without filters only for their rinse water tos fibers may lead to wide dissemination 1935 Doll R. Mortality from Lung Cancer final filtration es studies in animals and to the deof such fibeorfs local malignant tumors as 10. Workers Brit J. Industr Mcd in Asbestos 81-86 1955 The preliminary report of these at the Office of the Hearing velopmenmtalignant mesotheliomas of the W. D. Asbestosis and 11. Buchanan Ann is on displayother scientific data in this well as similar to those and peritoneum Primary Intrathoracic Neoplasms Clerk Any be submitted to the Hear- pleura after inhalation of asbestos N.Y. Acad Sci 507-518 Tes1l9u6k5 and R. P. regard should that occur 12. Cordova J. F. H. of the ing Clerk : fibers blood asbestos in the total Asbestosis and Carcinomas Knudtson 1962 Certain parenteral drugs such as The problem of the worldwide Lung Cancer 1181-1187 E. B. Toker comunity fractionation products may be filtered filters environment to whichaddressing itself 13. Gross P. R. T. P. deTreville Babyak Experimental several fractionation tiimtesis ntohtrokungohwnaswbietsthocsertainty could scientific community is Environmental Pro- is very complex The in the has published M. Kaschak and M. A. cancer - The development of lung Asbestowsiisth pulmonary deposits of chrysotile Thus far whether the more viscous products ter- tection Agency of April 6 1973 38 FR in rats asbestos dust Arch Environ Health be successfully processed through FEDERAL REGISTER standards for 343-355 1967 minal membrane filters without com- manufacturing identity strength 8820 national emission asbestos milling and that asbestos I. J. J. Churg and E. C. Ham- 14. Selikoff and Neoplasia mond Asbestos Exposure safety promisingor The precise effect of - based on the determination stand- JAMA 23-26 1964 purity quality pad filtration removal of is a hazardous air pollutant Thisthe fact 15. Borow M. A. Conston L. L. LIitvsorAnsessoe- asbestos Ref 46 and 47 is not com- ard has been developed despite stand- N. Schalet Mesothelioma and and JAMA 587-591 pyrogens at the present time the EPA also recognizes that a ciation with Asbestos Curently Fod . Pletely known Food and Drug Adminis- ardized reference method has not been 1967 with E. McCaughey and surveying the industry for developed to quantitatively determine 16. Elmes P. C. W. T. of the Mesothelioma material the use of asb- content of asbestos in a O. L. Wade Diffuse Brit Med J. 350- concoming survey will the the status of this problem is Pleura and Asbestos committee record The present the report of a 353 1985 : O. L. Wade Relation- be incorporated incorporated in the public summarized by to a meeting spon- . 17. Elmes P. C. and to Asbestos and - Although the major experimental experimental prepared subseqIunteenrtnational Agency for ship Between ExposiunrePelfast Ann N.Y. have involved inhala- sored by the Ref 52 The Food Pleura Malignancy 132 studieosf offibaesrbsess too s to simulate occupa- Research on Cancer review of this Acad Sci D. " ttiioonnal exposure several studies have been and Drug Administratifoonl'lsowing areas of P: e. r1i8t. oEnnetailckTnuapmoJr. In Asbestosis performed to investigate the effect of report indicates the are necessary necessary Ind Med 20-31 1984 Sloper epidemiology fibers parenteral inoculation of asbestos further research that particularly 19. Fowler P. B. S. C. Asbestos Asbestos and PYerde In 1958 Schm^/hlRef 48 refpiobretresd and 1 Further to asbestos Warner respect past exposure Exposure Exposure to hied J. the Pleura Brit 211- to - implantation of asbestos tissue with of sites other than lung thelioma of crumbs in either the subcutaneoudsevelop- and cancer and peritoneum 213 1964 20. Hammond Works lead to the or in the peritoneum sarcomas ' pleura Assessment of excess cancer risks of malignant tumors a to only one type of longer . Neoplasia Among Insulation Works _ Churg with Special Reforunce in the United States Ann N.Y. mienn1t1 of 30 rats which survived following exposure to Intraabdominal Neoplasia than 15 months after such implantation | fiber reduc- 49 50 51 b Investigation of whether Acad Sci 519-525 1965 of D. O'B The Pathology 21. Hourihane Their As- Roe and his colleagnuuemsbRerefof studies in of asbestos exposure in lungs below and an Analysis of Mesothelioma Thords have performed a were injected sub- tion causing asbestosis abolishes excess sociation with Asbestos Exposure which asbestos fibers into the flanks of cutaneously Ref 49 crocido- those risk of carcinoma of evidence of an in- 19 268 2718964 H. Pistawka Meso- 22. Lieben J. and Arch En- experiments mice In the first fi- c Investigation from as- thelioma and Asbestos Exposure lite amosite and chrysotile asbestos in- creased risk of cancer resulting food or viron Health 559 5613967 and W. M. bers were used and each animal was bestos in water beverages R. II J. L. Grosh of 23. Mann Associated with jected twice subcutaneously with 10 milligrams of in both fibers in liquids used for the administration drugs 521-526 O'Donnell Mesothelioma Associated Asbestosis Cancer W. T. E. O. 1968 L. Wade and flanks with an interval of five weeks be- Development of methods of quan- 24. McCaughey to Asbestos Dust and saline the injections Seven of seventy- 2 assessment size analysis and P. C. Elmes Exposure Brit Med Mesotheliomas tween characterization one mice which survived 40 weeks or site tumors In titative of particles and fibers Diffuse Pleural J. 1397 1962 A. Harper O. A. Elat- more developed injection REFERENCES 25. McDonald D. of one mouse developed a meso- of air tar and J. C. McDonald Epidemiology in addition underlying of the peritoneum 1. Asbestos the need and feasibCiloimtmy ittee Mesothelial Tumors Primary Malignant thelioma site injection site The injection controls Report of the pollution Atmospheric Pollutants 914-919 1970 Canada Cancer and H. Thompson the sarcomas were produced by all three addition Roc et al Biologic Effects of on Academy of Sciences 1971 National W. Fibrosis of the Lungs due 26. Newhouse M. in the of Mesothellal Tumors Epidemiology Acad Sci 579 583 types of fibers Itnhat the asbestos fibers 3. Cooke of Asbestos Dust Brit London Area N.Y. Ref 49 showed the local to the Inhalation 1965 and were widely disseminated from rather Med J. 147 1924 Asbestosis 27. Owen W. C. Mesothelial Tumors N.Y. Acad sites being deposited 3. Cooke W. E Pulmonary to Asbestos Dust Ant injection | the serosal surfaces of the Brit Med J. 1024-1025 1927 L selectively on " and the retroperi- W. J. M. Dallavallo T. 4. Dreessen A 1985 Exposure Sci 674-679 674-679 J. J. Churg and E. 1. ITam- abdominal organs on the perl- tonical structures as well as and adja- Edwards J. W. Miller Bludy of Asbestos in and the R. 12. Sayers Asbestos Textile 28. Seltkoff L. mond Relation Between Mesothelioma Exposure to As- J. ony 2 cardium diaphragm pleura of the lungs and heart T to the Public Health Bull 211 Washing- Washing- IndusUtSryClovernment Printing Office 1938 ton bestos and Mesothelioma 560-585 1963 : Asbestos and Henith in cent parts - serosal surfaces reacted vigorously in 10 126 pp 20. Wright G. W. Dis 407-170 1969 of the asbestos fibers and presence of mesotheliomas McDonald S. History of Pulmonary B. Asbestoriu Brit Afed J. 1026-1026 1026-1026 1027 1969 Am Rep Resp 30. Selikoff I. J. C. Hammond Hammond and J. J. of 71 mice malignant developed AsbestorMiuerewether R. A. The Occurrence Churg Asbestos Exposure Beeking 106-112 the thorax and abdomen Kanazawa 6. Fibroids and Other Pulmonary Pulmonary Neoplasia JAMA 204 Ref later study 51 of in Arbenton Workers J. Ind Hyg Hyg J. O. C. A. loggs In 1930 al showed that after subcutaneous et fibers in mice fibers Affections and 12 239-357 198-232 G. Pulmonary Asbestosis ReMills 31. Wagner chand Diffuse Pleural Mosothelioma in the North Western Capo injection of asbestos disseminated could found to have to 7. of Pulmonary case Ming Med 490-499 1930 port a Asbestos Exposure regional and distant lymph lymph nodes spleen VOL 38 NO FRIDAY SEPTEMBER 20 1973 FEDERAL REGISTER PROPOSEDPROPOSED RULES oO Brit J. Ind Med 17 260-971 3.pion P. Two Oases of kalikgaaliga Report Committee 81. Report of the Advisory on brane filters is also requested the Anbentas Unmeera to the Director of In- comment comment on methods of quantitative forntional agency for encarch on Cancer asesment assessment size analysis Brit J. Industr Mod 100-180 100-180 1973 and ) acterization of particles fibers is develop The Commissioner recognizes that it essential in order to develop Hammond food and drugs | which accurate Asbestos Selkoff L. J. and C. " P-P- not possible to eliminate all sources of| methods compliance on accurate Epidemiolo III Community contact with compliance can be based and fairfairfair based Nonoccupalioual Environmental Exposure Am Pub Health 58 . in virtually Therefore pursuant to provisions of the Federal Food Drug and Competic 1938 pidemiology ... of Diffuse Diffuse and altering sytems systems the Tumors Evidence of an which food many Act sees 402 502 701 62 Stat 1048- systems used in 1047 as amended 1050-1051 as amended Shidles in South Africa and 0.8.C. Kingdom 4. N.Y. Acad Sci manufacture of food and drugs and la found in some substatices notably water 1055-1056 as amended 21 352371 and under authorityauthority delegated K. Commissioner dy HammondHammond A. M. Chup Nicholson L. J. Scitkoft and Biological Effects of Asbestos at the National Institutes of Auvilver 1973 Auvilver L. and W. Thurlbeck The of und tale used in the manufacture and processing of food and drugs Neverthe- less the Commissioner also recognizes that asbasbeesstostos mbers perform no functional purpose in tule and are an unnecessary contaminant It is therefore reasonable to him 21 CFR2.130 the of Pood and Drugs proposes to amend Title 21 of the Code of Federal Regolations as follows 1. In Part 121 by amending121.101 d 8 by alphabetically adding to the Asbestos Bodies in the Lungs at Can Necrospales in Montreal 1170-1102 1986 Med Bodies Human , D. S. Totten and P. Gross Bodies in Lungs at Au- * JAMJAMA A 192 371-373 1965 Criteria for a Recommended StandOccupational Exposure to Asbestos to require precautions to be taken the manufacure or rood and drugs as part of good manufacturing practices to assure any that the amount of asbestos fibers Accordingly concluded to take the follow- toner table a new item and in paragraphs h and 1 by revising the entry for tale to read as follows r 121,101 Substances that are generally recognized as safe . a * fi e eo y Committes National In- ing action d * Med for Occupational Safety and Health 1. In view of the demonstrated hazard liation No. ISA 72-10287 1972 in animals from injection of asbestos . ach J. R. and H. Ayer Measure- proposing Asbestos Exposure J. Occup fibers the Commissioner is proposing that 1968 _ the good manufacturing practice GMP Product . Tolerance _. Limitations or restrictions * Swinburne L. M. The ingestion of as- regulations for drugs be amended to re- . eo 8 * unpublished ' rats data personal quire that filtration procedures for pa- 8 Miscellaneous ..--- eee ication to Bureau of Foods FDA - - rental drugs shall utilize either a non- and general food purpose Smith W. L. Miller R. E. Elsasser and containing or releas- additives D. ing D Hubert Tests for Carcinogenicity of filter such as a membrane filter or if * : * : oy tn * . 132 . stos An N.Y. Acad Sci 456-488 an containing filter is neces- Talc free of asbestos In ene cee ene -. chewing gum WestlakeWestlake G. H. J. Spjut and M. Sary shall also utilize an additional non- fibers as determined in : Penetration of Colonic Mucosa by containing or releas- 121.2006 base and as an anisticking agent in forms usedin . ee 2030-2083 Cuningham whe Chemicals imum Comisioner Commissioner intendsto determined Nature Pontef1r9a7ct1 pro- asbestos fibers ting is Particles Electron Microscopic in Rats Asbestos Dust Lab In- 2030-2083 1965 . Cuningham II and R. Asbestos Fibers in Beverages and Water 232232 332-333 ing filter such as a membrane filter to reduce asbestos fiber content to the min- level feasible unless such a subse- will identity | 2. The + a (a) * * * Tale free of in 121.2006 121.2006 *. molding food . shapes . Py _ as ; through Digesmulgate final the . mulgate a regulation for tale under 121.2006 as soon asbestos food deter- _ fi i# * %* Y ee os or 7 352-353 Nature 243 a is validated . . Such as part ofa which earlier proposal in metliod is proposed republication of the no methodology fibers Talc free of asbestos in 121.2006 as determined ' Boos ee wae ce felt Tui C.and SM ci. encWer1ig7h1t-T1h7e3P1e9n7e2- on of Pyrogen Infusion and Other ravenous Fluids by Absorptive Filtration Aus AusSurg 412-425 1942 : 47. Remington's Pharmaceutical Sciences Puenteral Preparations Pyrogens Chap- 82. 14th Ed pg 1524 1970 43. Schm^/hl D. Cancerogene Wirkung Asbest bei Implantation von Ratten Zeitschrift f^...r Krebsforschung 561-567 1988 was specificd The Commissioner Commissioner con- 2. In Part 121 by amending uclnuddeers Ptahratt 1a21ficnaalnnroetgubleatpiroonmulfgoartedtale by adding the following new until a reproducible and accurate method $ 121.2006 Tale na ; naturally can be specified for compliance purposes a Talc is - subject 3. The Commissioner is also proposing hydrous magnesium silicate | silicate that any tale used in the manufacture or a prior sanctifoornusue se in coating coating processing of drugs meet the specifications for this substance that will be imposed by 121.2006 with ished rice It is found in naturaldeposits depositsdeposits that may be contaminated fibers asbestos _ 49. Harington J. S. and F. J. C. Roe Stud- 4. The Commissioner realizes that the the of Carcinogenesis of Asbestos Fibers and the Natural Fibers Annals of the N.Y. issues raised in this notice are complex and have widespread ramifications Com- Academy of Sciences 132 439-450 1965 ment is requested on all aspects of the Academy M. Roe F. J. C. R. Carter A. Walters public health significance of ingestion Harington FibersJ. S. The Pathological Ef- and injection of asbestos fibers Since fects of Subcutaneous Subcutaneous Injections of Asbestos adoption of any new filtration require- in Mice Migration of Fibers to Sub- ments may require use of additional - sothelial Tissues and equipment otheoliomatta heliomata Int J. of 19617 967 Induction of MesCancer 628-638 comment on the availability of appropriate equipment the need for 51. Kanazawa K. M. C. Birbeck R. L. Roe Carter and F. C. Migration of Asbes- ~ tos Fibres from Subcutaneous Injection Sites in Mice British Journal of Cancer 96- + 106 1970 use of containing filters as con- trasted with filters which contain no asbestos and the time needed to obtain and begin using asbestos- containing final filters such as mem- b Good manufacturing practice re- quires that talc be free from asbestos fibers to the maximum extent . prac- ticable Accordingly any food or food- packaging material containing tale that is not free from asbestos fibers as deter- mined by the method set out in para- graph c shall be deemed to be adul- section terated in violation of of the act 402 a 1 c The following method shall be with used to determine compliance section this No. 188 I FEDERAL REGISTER VOL 38 NO FRIDAY SEPTEMBER 28 1973 Se Het aL ONECART MOE IIE EN PENI NEG TNS . 27080 we ' PROPOSED RULES 1 The various kinds of asbestos are we distinguished from talc and from each - other by their refractive indices other_ optical crystallographic properties and moipliology as determined with a polar- izing microscope Methods of the Asso- limit for the presence of these asbestos assure purity of talc at least 99.9 percent free of amphibole types of asbestos fibers and at least 99.99 percent free of chrysotile asbestos fibers 3 Optical crystallographic charac- teristics of asbestos minerals and tale EXAMPLES OF REFRACTIVE INDICES n ciation of Official Analytical Chemists 11th Ed 1970 Sections 36.541-36.543 Substance na n" ny Extinction Elongation p 717-721.1 Talc occurs mainly in the form of thin plates which may appear fibrous when scen edgewise in micro- scopic view Beta and gamma indices of talc vary from about 1.575 to 1.590 beta being very close to gamma All of the principal refractive indices of chrysotile are less than 1.590 Chrysotile Actinolite oelenene 1.614 1.615-1.65 1.615-1.655 1.615-1.655 Amo 2. cs .c.cei eetce eeeee 11.663 Anthophyllite 1.630 1.630 1.625-1.65 1.625-1.665 1.641 1.64-1.68 1.64-1.68 1.64-1.68 Inclined Positive Positive asbestos is therefore distinguishable 1.635 1.640 1.640 from fibrous looking talc particles in a 1.574 refractive index liquid and the other five amphibole types of fibrous Chrysotile weeweneneence a 1.493 1.508 1.508 1.529-1.5 9 1.638 1.638 1.504 1.504 1.512 530-1.564 530-1.564 ewewnnene ee cee 1.652 1.652 1.517 1.522 1.537-1.567 1.537-1.567 -1.55 Leelee _ Positive asbestos from tale in a 1.590 refractive men nemeen meee 1.555 "y v6 * index liquid The tabloef optical crystal- for L Jographic properties talc and the asbestos minerals in subparagraph 3 indices which are 1.543 1.543 calc 1.550 1.550 1.557 1.557 1.560 1.560 1.695 1.695 1.695 1.555 _ 1.557 . 1.557 1.560 ...--------+ 222- 1.62 97 1. .697 Parallel 1.697 _22 ews. ~ ~ Negative - encountered in these minerals samples may have indices higher or lower For Scherement of optical prop- 007% practical 1.697 1.700 1.703 2-2-2 e 2 ee 11 2 nee Positive 1.575-1.590 1.538-1.54 eueeceeee------ Parallel or or no 1 589 1.889 erties Scherement Scherement table particles iden- 0 : . Un Un Scherement Scherement this method should be at least .~ : ...m or longer , ce 2 Weigh out 1 milligram of a repre- - - sentative portion talc on each of two en " microscope slides Mix the tale with a ef needle to spread evenly over the suitable area on one slide with a drop of 1.574 refractive - index liquid and then the other with 1.590 liquid and place on each a square or rectangular cover glass suffi- | ciently large so that the liquid will not run out from the edge ca. 18 mm square and will provide a uniform par- ticle distribution Fibers counted by this 3. In Part 133 by adding the 1.613 - 613-1.626 613-1.626 1.814 1.602 1.618 1.613-1.631.6138-1.638 1.604 1.612 following ...m ...morgreater or less Count and record the number asbestos fibers : found in each 1 milligram as determined from a scan of both slides with a polariz- ing microscope at magnification of ap- proximately 400 X. In the 1.574 refrac- tive index liquid chrysotile fibers with Indices less than 1.574 in both extinction positions may be present in the 1.590 refractive index liquid the other five amphibole types of asbestos Albers with . indices exceeding 1.590 in both extinction positions may be present Check the extinction and sign of clongation for tentative identification For specific * identification of asbestos fibers make additional mounts in appropriate refractive optical - Index liquids and refer to the crystallographic data in the table A not more than 1000 amphibole new paragraph 1 to 133.6 to read as . follows 133.6 Components * * * * * i Talc is a naturally occurring hy- drous magnesium silicate which may reasonably be expected to contain asbestos fibers which may be injurious to health Current methodology cannot as- sure the absence of asbestos in talc Accordingly any drug drug ingredient or drug packaging material containing tale that fails to meet the specifications of paragraph c of 121.2006 of this chapter as determined by the method set out in that paragraph shall be deemed to be adulterated in violation of section 501 of the Act ; 4. By adding the following new paragraph j to 133.8 to read as follows 133.8 Production and control proce- dures a filter If use of such a filter is required aandditional asbestos or releasing filter such eS & membrane filter shall subsequently be used to reduce the content of any asbosform particles in the drug or drug ingredient Evidence for reduction shall bo based on the use of the methods described " in Criteria for a Recommended Occupational Exposure to Asbestos Report of Review Committec National Institute for Occupational Safety and Health Publication No. HSM 72-10267 1972 Use of an achos- containing oa * * .- * 1 Use of containing filters Filters used in the manufacture of a Coples may be obtained from Chemists parenteral drug or parenteral drug in- No Association of Official Analytical Chemists - gredient shall not release fibers into such P.O. Box 540 Benjamin Franklin Station 2 Washington DC 20044 Tos : products Bsbestos containing or emi asthma enact, Copies may be obtained from Superintendent U.S. Superintendent of Documents Covernment Printing Offen Washington DC 20103 FEDERAL REGISTER VOL 38 NO FRIDAY SEPTEMBER 28 1973 4g 8 Se mea ee Ane i z aes bs yet En e Ba mM te sg met wom SNE ste, emy Denar PROPOSED RULES may on or before 1973 0le with the Hearing and Drug Administration 6-86 5800 Fishers Lane Rockville 20853 written comments prefer in quintuplicate regarding the petition and the Commissioner's proposal Comments may be accompanied by a memorandum or brief in support thereof petition background information re- ferred to in this proposal and comments received may be seen in the above office working hours Monday through Dated September 24 1973 oo -. M. SCHMIDT Commissioner of Food and Drugs IMR Doc.73-20711 Doc.73-20711 Filed 0-27-73 am Part 71 of the Federal Aviation Regu- lutions that would alter several Voic Federal Airways in the vichilty of Chteago III due to the planned decommis- stoning of the Naperville III VOR Interested persons may participate in the proposed rule making by submitting such written data views or arguments arguments as they may desire Communications Communications should identify the airspace docket number and be submitted in triplicate to the Director Great Lakes Region Attention Chief Air Traffic Division Federal Aviation Administration 2300 East Devon Des Plaines III 60018. All communications received on or before October 29 1973 will be considered before action is taken on the proposed amendment The proposal contained in this notice may be notice changed in the light of comments received An official docket will be available for The Naperville Naperville sioned about Jime of relewal creased cost of leave perville site and the fubite buildings effect that builbduildiings ngs plumed cinity would have DuPage frequency that it can serve in airway struc- ture Some of the airways in this vicin- ity would be realigned via DuPage in lieu of Naperville : This amendment is proposed under the authority of Sec 307 of the Federal Aviation Act of 1958 49 U.S.C. 1348 and Sec c of the Department of Transportation Act 49 U.S.C. U.S.C. ) 1855 Issued in Washington DC on September 1973 Social and Rehabilitation Service 45 CFR Part 221 - FAMILIES CHILDREN AGED BLIND OR DISABLED INDIVIDUALS examination by interested persons at the Federal Aviation Administration Office of the General Counsel Attention Rules Docket 800 Independence Avenue SW Washington D.C. 20591. An infor- CHARLES H. NEWPOL Acting Chief Airspace and Air Traffic Rules Division FR Doc.73-20703 Filed 9-27-78 am Service Programs Correction ' FR Doc 73-19242 published at page 21872 in the issue dated Monday September 10 1973 is corrected by changing 1. The number 233 in item number two of the preamble fifth line to 2. The code designation 221.6 a 3 mal docket also will be available for examination at the office of the Regional Air Traffic Division Chief The proposed amendment would 1. Realign V from Cordova Ill via INT Cordova 087 083 and DuPage III 253 radials to DuPage From the INT of Chicago Heights Ill 356 and South Bend Ind " in item number two of the preamble Seventh line to 221.6 3 i " ; 271 radials to South Bend 2. Realign V from Cordova Ill via 3. The code designation 211.3 6 INT Cordova 083 and Joliet ( in item number three of the pre- Ill 291 289 radials to Joliet Amble fourth line to 221.6 3 iii " 3. Realign V from Joliet Ill via INT Sj The code designation 211.6 a 3 ; Joliet 327 and Milwaukee [14 CFR Part 75 ' Airspace Docket No. WE AREA HIGH ROUTE Proposed Alteration The Federal Aviation Administration FAA is considering an amendment to Part 75 of the Federal Aviation Regulations that would realign a segment of 938R from Reno Nev to Maple Calif may Interested persons may paticipate in the proposed rule making by submitting . on vi in item number four of the pream- Die fourth line to 221.6 3 vii The code designation 211.7 b in Hom m ber five of the preamble fourth mumination 211.b9 ) Wis 207 radials to Milwau- such written data views or arguments as kee : : they may desire Communications should 4. Designate new VOR Federal Airway .identify the airspace docket number and Pontiac V west alternate from III via be submitted in triplicate to the Dirce- INT Pontiac 343 and Milwau- tor Western Region 207 kee Wis radials to Mil- Air Traffic Division * mumination mumination the preamble to 221.9 3 " o code designation ) 3 words of issuance number three first line and in 221.6 3 itself first line 221.6 " 8. The number now corrected to line to 6 and " in 221.6 4 221.6 4 fourth 5. Realign 10 from Plano III in- tersection direct to Chicago Chicago O'Hare III _ b Delete that portion of 10 which lies between Plano intersection and Niles III intersection : 6. Delete that portion of 10N which lies from Naperville via Neptune Ind intersection to South Bend Administration 1500 Aviation vard P.O. Box 92007 Center Ins 9. The word secured in 5 fourth line to secure ; 221.9 Approved September 24 1973 THOMAS S. MCFEE MCFEE Deputy Assistant Secretary for Management Planning and Technology FR Doc.73-20726 Doc.73-20726 Filed 9-27-73 45 am DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 7. Delete 97 from Chicago Heights Ill via Joliet Ill to Woodstock III An official docket will be available for examination by interested intersection persons at the Federal Aviation Administration Administration Offlee 8. Realign 97 from Northbrook III of the General Counsel Attention Rules direct to Janesville Wis Docket 800 Independence Avenue 9. Realign 100 from Rockford Ill to Northbrook Ill via INT Rockford Washington D.C. 20591. An docket also will be available for SW informal 077 and Northbrooks 292 290 radials ; examination at the office of the Regional Air Traffic Division Chief 10. Delete 116 from Joliet Ill to Neptune Mich intersection 11. Delete 116S from Naperville Ill via Grand Beach Ind to Keeler Ind 12. Realign 177 from DuPage Ill As part of this proposal relates to the navigable airspace outside the United States this notice is submitted in con- sonance with the ICAO International Standards and Recommended Practices direct to Janesville Wis Applicability of International International Stand- 14 CFR Part 71 Airspace Docket No. GL VOR FEDERAL AIRWAYS Proposed Alteration The Federal Aviation Administration FAA is considering an amendment to 13. Delete 218 from Rockford Ill to Keeler Mich 14. Realign 227 from Pontiac III direct to Rockford Ill 15. Realign 429 from Joliet Ill via INT Joliet 349 and DuPage III 183 radials to DuPage ards and Recommended Practices Practices by the Air Traffic Service PAA PAA in areas outside domestic airspace of the United States is governed by Article 12 of An ex and Annex 11 to the Convention on Civil Aviation which pertain establishment of air navigation and services necessary to promoting FEDERAL REGISTER VOL 38 NO FRIDAY SEPTEMBER 28 1973