Document VG9gBXgBnq5XKeO6bJ1DDwqd8

FILE NAME: Talc (TALC) DATE: 1973 DOC#: TALC081 DOCUMENT DESCRIPTION: Federal Register Notice m >xmk(^jsmmzmM iM M M 27076 PROPOSED RULES the enforcement procedures otherwise provided, he shall Inform the affected*' employees and official In charg-..of.-the' establishment of the danger and require > m r * k immediate- abatem ent,. including with draw al Of employees from the dangerous circumstances. ; ment, and a summary of steps being taken to the toterfytvto Pptect em ployees from being injured by,the haz ard. A copy of the.j>Jn will be sent to the safety and health/committee of the agency for appropriate comment. The head of eac,h agency will inform the Sec 133.---- Filters containing asbestos. Drugs passed through filters m ade wholly or partially of asbestos m ay reasonably ba expected to become contam inated w ith asbestos particles which may be Injurious to health when injected or ingested. Accord ingly, any drug or drug com ponent produced, . 1960.26 Polices of hazards. retary of Labor at regular intervals to m anufactured, processed or prepared using a (a) Each agency will establish a pro be determined by the Secretary as to the filter made wholly or partially of asbestos shall be deemed to be adulterated In viola :;r cedure for issuing notices of hazards dis mpreongtrepsslamn.adAeniyn cchararnyginesg oinuttthhee aabbaattee tio n of section 401(a) of th e Act. , covered upon inspection. Notices will de . scribe with particularity the nature of m ent plan will require the submission of 133.---- Talc c.onlaining asbestos. the hazard, including a reference to the a new plan in accordance with the pro visions of tliis section. Talc is a naturally occurring hydrous m agnesium silicate which may reasonably be standard or other requirement involved. Tlie notice will also fix a reasonable Subpart E-- Federal Agency Internal expected to be contam inated' w ith asbestos particles. Asbestos particles may be injurious time for the abatement of the hazard. A Evaluation to health when ingested or Injected. Accord copy of th e. notice will be sent to the 1960.23 Duties o f Federal agencies. ingly. it is n o t considered good m an u factu r official in charge of th e establishm ent. ing practice to add talc, directly or indirectly Each agency shall conduct an annual as a com ponent in th e production, m anu (b) I f a notice of hazard is issued as a result of a request for inspection under detailed internal evaluation of its occu facture, processing or preparation of any 1980.24(a) o r a notification of hazard pational safety and health program. Basic guidelines for this evaluation will be is ctrug, unless th e m a n u fa c tu re r'o r processor of the drug first dem onstrates by appropriate tests that, th e talc so used is free of under f 1960.24(c), a copy of the notice . ..of hazard will also be se n t to th e em sued periodically by the Office of Federal asbestos particles. Any drug or d ru g com ployee n r representative of: employees Agency Safety Programs. These internal ponent containing talc which has n o t been who rado ru"h request or notification. evaluations shall be utilized by each dem onstrated to be free of asbestos particles agency for the purposes set forth in the shall be deemed to be adulterated in viola fi.rdfc,>thUepoenfC'-"toclciipnt ocfhaarngyenoofticaenoef shtaabz-- ; applicable statutes and Executive Order tio n of section 501 (a) of th e Act. ' listonent will immediately post such no No. 11612, as described to 1960.1, and shall be maintained and made available Petitioners also request th at the Com tice, o r a copy thereof, unedited, a t or by each agency for review by the Office of missioner "immediately (within 30 days .r ntheearneoaticche polcaccuerraedh,azeaxrcdeprtefaesrrperdovtiodeind Federal Agency Safety Programs. - from the receipt of this petition >" promulgate as a- final- regulation a zero below. Where, because of th e n atu re of . Signed a t Washington, D.C., this 24th tolerance for asbestos re lic to - ;( j n the establishm ent operations, it is h o t day of September 1973, to.". , , .. intended for use.-fts a fo c i adustos, ,>.. practicable to post-, th e notice a t or near , . , J o hn H. S tender, suant to th e proposal puto (she! In tie each place of hazard, such notice will be posted, unedited, ih a prominent place Assistant Secretary of Labor. -FEDERAD; R-EGlSTa-O '12, 1672 '*37 . FR 16-197), and take whatever,, otfc. - p- ' w here.it will be readily observable by all [FRDoc.73 20707 Filed 8-27-73; 8 ;45 am ] tion th e Commissioner deems necafev y affected employees. For example, where to eliminate contam ination of too;? p"d establishment activities are physically DEPARTMENT OF HEALTH. drugs with asbestos. v . .. dispersed, the notice may be posted a t the location to which employees report EDUCATION, AND WELFARE A complete copy of the petition and its attachm ents may he reviewed a t the office each day. Where employees do not pri- Food and Drug Administration of the Hearing Clerk, Food and Drug Ad .marily work at or report to a single lo [ 21 CFR Parts 1 2 1 ,1 2 8 ,1 3 3 ] ministration, ,Bm. 6-86, 5600 F ish e s cation, the notice may be posted at the Lane, Rockville, MD 20852, during workASBESTOS PARTICLES IN. FOOD AND . tog hours, Monday through Friday, location from which the employees oper- , ate to carry out their activities. The of DRUGS The Commissioner has carefully re ficial in charge of an establishm ent will Notice of Proposed Rulemaking viewed the petition, its attachm ents, and to take steps to ensure th a t th e notice is not altered, defaced,' or covered by other m aterial. to- ' . The Commissioner of Food and Drugs has received a petition from the Center fo r Science.in the Public Interest, 1779 other available information, and has reached the following conclusions. Each conclusion indicates the source reference : a*' (d) Each notice of hazard, or a copy Church Street N W , Washington, D.C. upon which the conclusion is based and copies of all referenced m aterial are th ere o f will rem ain posted until th e haz ard has been abated, or for 3 working F20u0n3d6,, 1a5n2d5 t1h8ethESntvriereotnmNWen.t,alWDasehfeinnsge- available from the office of the Hearing days, whichever,is later. . Clerk. " ton, D.C. 20036, requesting promulgation "Asbestos" is a generic term for n num 1960.27 Correction o f hazards. of regulations under the Federal Food, ber of hydrated silicates that, when (a) T he procedures for correcting haz Drug, arid Cosmetic Act to prohibit the crushed or processed, separate into flexi ards will include reinspection by the of adulteration of food and drugs with as ble fibers made up of fibrils. Although fice of the designated safety an d ,h ealth bestos. Petitioners request th a t the Com there are m any asbestos minerals, only official to determ ine w hether th e corree- missioner publish in the F R six are of commercial Importance. i tion was made. If upon reinspection the ederal egis Chrysotile, a tubular serpentine mineral, ter "immediately (within 30 d ays)'' the accounts for 95 percent of th e world's I csaofreretyctaionnd wheasalnthotofmfiacdiael, sthhaelldmesaikgenattheids following proposed regulations: ; to' production. The others, all amphibolc.s faet te o w n to the head,of the agency for 1. S u b p a rt' V of P a rt 121 is am ended by (crystals with 3 groups of metal Ions), are '& . appropriate action. , , .a d d in g Uie follow ing sectio n ;- ' amosite, crocidollto. onthophyllite, trem - (b> If in the' judgm ent of the deslg- 121.---- Fillers containing asbestos. oilto and actinolite. These asbestos minerals differ in their m etallic e'e~ : nated, safety and .health official nbate- . 'TrKHls that, have como in to co n tact w ith m ental content, range of finer, diameters, m ent of a safety or health h azard will fitters m ade wholly or p a rtially of asbestos flexibility, harshness, tensile sirens th, riot be possible within 30 working days, m ay reasonably bo expected to become con- surface properties, and other attributes the official in charge of th e establish m ent will su b m it'n abatem ent plan to Lam inated w ith ashes to particles w hich m ay be Injurious to ..health when ingested. Ac th at determine their industrial uses mid . th e desitosted safety and h ealth official cordingly, any food or food nddnive produced, which may affect their respiratiility, <iep- with a copy thereof to the head of the m anufactured, processed or prepared using psltion, retention, translocation 6 fitter m a d Wholly o r p a rtia lly of asbestos biologic reactivity (Ref. 1). and i agency and to .th e Secretary of Labor, sh a ll be doemed to bo a d u lte ra te d in violation, Such, plan, will contain an explanation of . of ficcMon 4.02(a) of th o Act, Many products such aa cement, floor- i th e clrcumtf an tes of th e delay, in abate 3. hurt 133 is amended, by'adding the fot- tog, shingles, pipes, filters, textiles, etc., ment, a proposed timetable for the abate lowing section; - contain asbestos of one kind or another. FEDESAt REOiSfER, VOl, 3, NO. 188-- FRIDAY, SEPTEMBER SB, 1?3 PROPOSED RULES were totally cleared by the gastednks* u ; j ph> m vnl variations among mioi i ' ' pM *\ IWt'' w w t to the chimera <i{ K f f & W Hot f l i t i o m d l y tinel tract lu 48 hours and. n ;> ; d . u i j , wn detected to tta- anim al to, the to ,f Jvl. u ..* Uuiing the use of the- prod 11 n n J d There is 6 to 7 fold luermea duif 1 week. The ytutroinovescirud tract > >i%v>likelihood o f m oil fiber release m 1 mu Ciint'yr hi ashsto$ wm'ltom which Of the r a t seemed to provide an etreetive . a .I;'-; pn-domiuantly on tiro iso, with t:. fibers ra n be dislodged and on t n * Amw W ** to 14 * * after linaetof ex p o su rean d * ,t t a t i t e m t a t 20 harrier to penetration. In a published study by W. E. ffimtm u to which the- use of the prod yearn Utefa. 0 through 10). boven pel ' v{ deaths in asbestos workers are el al (Ref .41). bamste-vs m aintained on ' : the fibers, Almost nil a- {" ,<.>-5* fiber I In -th e United atot.os caused bv pleural a|l<* peritoneal mono- n diet of 1 percent chrysotile or amosite tiiohonia'dtofs. 10 through 33). Hus is a through life, had no gastrointestinal 'nt.-iiufaetwrlng products becomes 1 -U:y h-mut within the products and marked increase since this tumor is ex- tu m o rs. A report by , , Westlake, ,, .. , Spjnr. and musHy uintotuoes little actual abrasion tm i'cly rare in the general population. 'i hero is suggestive evidence concerning Sm ith (Ref. 42) indicates th a t tne ra t J v, ,u r fcWtwo being discarded. Asbestos . ,. a n t products (accounting tor most o increase in the rate of gastroiute.itl- colonic mucosa is penetrated by <tnysotilo after feeding a diet containing 5 per }SV; i A u>s used lu th e United St.at.os, rmi malignancies lu asbestos workers cent asbestos for 3 months. ijr-i and floor tiles are in this cato!,,,sv. Same asbestos-containing products, (Ref. 34). , , ., ' . There is considerable evidence th at most human lungs harbor thousands or Cunningham and Pontefract (Ref. 43 and 44) injected chrysotile fibers (9.4 and 94 x 10") directly into stomachs of f n,H as brake linings, are subjected to *g m otion; their ra te of wear is con- itetemUte and a t times they are almost millions of asbestos fibers although most people do not have asbestosis (Refs. 35 rats. Fibers were found in blood and ;v>;.metoly worn away. In -the case of through 37) This is due to the ubiquity other organs, 2-4 days after treatment. Control rats, although having no asbes tl, aka linings, th e application of force la so intense and tire h eat created so great of tho'substancc. Some of these fibers are chrysotile asbestos, and amphiboles are tos in blood, also had high levels of Orat roost chrysotile fibers are destroyed pfirboebrsabilsyreplraetisveenlty aslmsoa.llTinhismonsutmpbeersronosf asTbheessteoswinorktiesrssuefso.und that, whereas the by being converted into another subSiian.ee which is non-flbrous. 'Neverthe- not occupationally exposed to asbestos tap water in Ottawa (having a filter ii-m, an appreciable percentage (l to 3 cooccmuppaarteiodnwaliltyh tehxeponsuemd.beTrhs efosuynsdteimn atthiec ppelar nlti)terc,ontthaeineqduaalibtyoutof2 fmibielrlisoninfibseorfst percent) remains as fibrous asbestos, Un J liber release from products such as application of quantitative techniques, drinks and alcoholic beverages purchased iubrvtos cloth, paper and sprayed fire fmibeearssu, riisngneebdoetdh tocodaetefidneaandgraudniceonatteodf imniltlhioenOftitbaewrsa paerer a lirtaenrg. eEdvfernomwi1thtoth1e2 . , jctiiiir m aterials is a serious source of eKWion. Tlfis usually occurs in densely accumulated fibers for correction*with technical problems of methodology, this populated areas. Most of th e pines-da? ianncdidehniscteoroyf odfiseenavseir,onomn etnhtealoenxepohsaunrde,, stheeemassbtoesitnodsiccaotenttehnat t minaysobmee abbeovuertagthees byariug drinking water arc oi a mixture of cement and asbestos. on the other. ( ct> fr* /V ) same as in water, whereas, in others, it Solid wastes produced during m anu asbTehsetoms eftihboedrsoloofgyvfaoryr iqnugansitzifeiscaitsiosnucohf mtoacyobnecluindceretahsaetd.wTahteurs,anitdismraenasyonoathbeler facture of asbestos-containing products, -<aa of such products, and demolition that the results obtained in one labora beverages for human consumption eon- can be emission sources. These waste m a tory may vary substantially from those tain substantial amounts of asbestos X .iris nro usually disposed of without in another. An inter-agency govern fibers. ' ',.,.rr;l to th e ir potential as emission m ental task force together with other There is some evidence th a t asbestos r , '.,c u . Alternate, m ethods of disposal scientists working in this field is cur fifiers^i^yrem ov^^om ^^sbegyjg^iiij^s cU.,a roeifit Li commingling of asbestos rently attem pting to develop standard rial. In a prellfrtMiry experiment per , n! il'i-ag wastes w ith municipal wastes technology which can be applied to the formed by the Pood and Drug Admmis- 'A (a a dumps and th u s create a long- identification and qualification of asbes tration, asbestos was added to distilled c. A "ion source. . ' - tos fibers. The Environmental Protection . w ater and dispersed evenly by the action / x 'j . r t '3 ilLeis thus->re ubiquitous in. Agency is currently investigating four of an ultrasonic 'generator. Electron ,, r, v and a large percentage of the, separate techniques in order to establish microscopy of this m aterial clearly . m o trci4. The am ount of this m a- th e best m ethod for identification, quan 'showed large num bers of asbestos fibers. K -i.i wJii'h additionally is added to the tification, sizing and typing of asbestos '.This m aterial was then filtered through t..vhx nmc-nt and to food and drugs by particles and fibers. At present, the Na 'a n asbestos filter, -and fc-ltcu-on mte,,o~ t h : use of asbestos filters is not known. tional Institute for Occupational Safety ' scopic exam inatkn of the filtered luate- Therefore it is obvious th a t th e presence and H ealth (NIOSH) recommends,- as' a' rial showed tvreduction, in ine nirnb;,.- of of asbestos in these products is only one technique for sampling ,of air, a method . asbestos fibers. . small source of exposure. Asbestos inhalation has been known to be an occupational hazard in workers in asbestos mines. The asbestos is inhaled and lodges in the lungs causing the de velopment of a fibrotic disease known as "asbestosis." Asbestosis, or abestotic pneumonoconiosis, was the first clearly demonstrated adverse effect of asbestos in man. I t is characterized by a pattern of roentgenographic changes in the lung consistent with diffuse interstitial fi brosis of variable degree and a t times with fibrosis and calcification of the pleura; clinical changes th a t include fine rales, finger clubbing and shortness of breath, each of which may be absent in an individual ease; and physiologic changes consistent with a restrictive lung disorder (Refs. 2 through 8). . based on counting fibers greater than 5 . microns in length using phase contrast illumination a t 430x magnification with a 4 millimeter objective (Refs. 38 and 39). This technique is currently recom mended for liquid materials until more accurate and sensitive practical methods are developed. However, as indicated be Nicholson and his colleagues (Fite. 45.) investigated a num ber ox samples of p a r enteral drugs and found atelestos iibsrs. Based on th eir report a study was under taken by the Pood and Drug Administratlon concerning contamination of par enteral drugs with asbestos. Although the data are still preliminary, the following low, another method Is proposed for observations are pertinent. Parenteral analysis of asbestos fibers in a material drug samples were collected from a numsuch as talc. The evidence concerning tire possible hazard from Ingestion of asbestos par ticles is contradictory and inconclusive; In an unpublished study by L. M. Swinburn (Ref. 40), asbestos particles were fed once a week to SPP W istar rats for 16 and 18 weeks. The m aterial was administered in butter. Although the par ticles were of the size range known to microscopy, 11 of 13 samples had clear- cut evidence of the presence of asbestos, one sample was questionably positive, and one was negative. The number of fibers ranged from 2 to 27 in-the positive specimens of variable sample size. Using electron microscopy, 12 of the 12 samples examined were positive. Quantitation is . not yet complete. . ` In these workers in asbestos mines, produce tumors by other modes of ad J jh js s iir v ^ s e v e i^ g O ^ j^ malignancies of the lung and of the body m in is tra tio n , n o tu m o rg e n ic effect w as lining tissues, namely lung cancer and noted. W ith a single large dose, th e fibers Tlis^s*lrTtorsTTour*firms use suen intern FEDERAL REGISTER, VOL. 38, NO. 188-- FRIDAY, SEPTEMBER 28, 1973  .- > ti* 707 ^ A ^ 'S S S '.S K s s ,, V ,,,,,ir.r ) and two firms use asbestos filters only for their rinse water, without PROPOSED rules kidneys and occasloi^ally to b ra rt tissue suggesting th a t some asbestos may ew U ahiLCUthelra 'is experimental evidence th a t narcnteral administration of asbes ft Sooer W. B.. "P ulm onary Ashestosia: A re p o rt ^ 'a case a n d a review," Am. Sev. T-ubere, a . Sm ith, "Pul- fil The preliminary report of these studies regard should be submitted to the Hear wweellll aass malignam- nu., , i,mffarr t,o. tthhoossee & S 5 ? SSTEU u, *" 72:81-86, 1065. "Asbestosis and Primary UCIih ra th o ra c lc Neoplasm s," A nn. f i The problem of g . f f " f ^ d S e Stored environment, to wnicn ^ itself, lssciveenrtyifcicomplex. lU e h n v ^ in Pthroe- d e v e l o p ^ n t Of l u m c a n ^ . tection Agency h a s p h s h S h ^ r l l d t ? s v " ^ . PE- i r o n . H ea ltK mioal m embrane fllurs , ^ lthoi p r,,Vh q&Sr2rssai S f o r effet 1 asbestos nad filtration. on removal of : i S f I p\TO"cns "(Bef. 4 gK J5 i f s ' e S o ^ 9 X7 J-, J- C hurg a n d E. C. H am - ' m ond `A sbestos Exposure a n d Neoplasia. " ^ ^ o r m f M 6 A 'c o n s to n , L. L. Llvoruese a S r= s - * , , nn-roving the inctetry for s S iiiS r A s - : ' , .-on^THinff-thc use o f * - -*; . ru.^ohs of th is survey will s s is e H f e be m t m ^ A to the public w J ^ - AUaor.'U tl*0 major, exp erim en ts Alt t ^ inVoiveu tohala- S r 4 ^ b s e w e n t to a meeting spon- P le u ra and. Asbestos, Bt%. - 85i 7 .1Elm es, P. C. a n d O. L. W a d e .'^ Ship' Betw een Exposure t e / > s eb <^ Pleura Malignancy m r M . - , tm n lS filers so as to' sim ulate pccupa- ' n n tm ru g A dm inistration's review of this A cai. S et, i32:p4 -5u<..t^'is . p.ntickuap. s. >- p .-o `i'" . a . ,, . f- m iin o "sure several studies have been K S g a t e the effect of report t e s the following areas of peritoneal T um or, in- A s - . - C . , " ' fu r th e r research are necessary. , , mil. m i ; `f t o ,, . ,, ui,-: r, r . f n ) F urther epidemiology, particularly 19. how ler, P. . o., - i - . j tv .-v w -irs e r Exposure to asUw .-js u . - hv, R - r e e t to past exposure to asbestos S ; of th e P leura." B n t. n * l . J , ^ S f S S S . "t 1* * " > la" B' 213. 106-1. r* ' I 3 F-A'koff e-rd J- :z & & a , s a a J E ~ pleura, and peritoneum. 20. H am m ond, E. C., i- . n, Ca) Assessment of excess cancer ris Cmintihrge "UNneitoepdlaSsitaa tAe sinwwitihg ^Espue5,e!t:teVl ^Kr^{cj.rr-'"c^e S t i f S f f i S S f n Of -To ra ts which survived longer following exposure to only one type of S to traab d o m ln al Neoplasia. A n. " S a n 15 m onths after such im plantetm n Roe and his colleagues (Ref- 4 9 5C) 51 have performed a wl^ h f ^ f v m r t 4 9 ) tafo th e flames of m icTVn the first experiments croeidou te ainosite end chrysotlle asbes.o.> _ ^ bars were used and each am m alw as . ,_j t'vire subcutaneously m bot.n se flb(b) investigation of w hether reducf ochor,t.ft<? exposure in lungs below * * -- risk of carcinoma. (c) Investigation of evidence of an tocreased risk of cancer resulting from os i ' L m water, beverages, food, or liquids used, for the adm inistration of dl"?2)' Development, of methods of quantu rt voassessm ent, she analysis and charactcrla&tton of particles and fibe References . , the need and feasibility of air om ;;nw ra o " to ^ b S U W W 79:268-278. 1901. pictawfea, 22 Llehen. 3. an d H. 1 u n w k * theHoma and Asbestos Ar . . viron. Health, lh 5 o 9 503. h t a wsth v ;. u . t> T-imf'Q "Expoiiure to Asnesws Diffuse' P leutal Mesotheliomas, -n 11 J., 2:1397.1963. 25. a H arper, O. A. E la t* Epidemiology of w S a r s s the iniection site, The Ib.MMU ncrntrolH," R eport of the C om m ittee C anada," Cancer, J 5 .91 - 0. ^ pa<>n> Pl nlo1<>t?to JiHVet.s of A tm ospheric p o llu ta n ts , sarcomas were produced by ah three Academy of Sciences, 1071. *"V r ,t!oUe W. P!., "Fibrosis of the Lungs due L ondon Area," N .Y. At&. to^thfi iuhttlatlou ot Asbestos D ust, B n t. S S y on the s e ria l jurfneeso the abdominal organs^ anefi y ^ elt,crl_ toncal 'structures as well ife on d ta cerdium. diaphragm, pleu a and J c e r t parts of the the E - "Pulraoimvy Asbestosto." 2:1024-1028,1927. m 1` i* rcr.-,en, W. C.. 3. M. DtUlttValle. T, L. . - o t n r . i ; .1 W. Miller, Hurt n . it. Sayers. A j'r A'jb'-slci hi the. Asbestos T extile ? Un,Rrv " Pa l,ml(h . 3 , WasblnR- to'o 'if S* G overnm ent P rin tin g Office. 10.S8, 106^ . ,, ,,,, w n "M csnthcUh Tum ors and 27. Owen, Vt. n r. Aral. Exposure to AshestoeiDnst, A n h.A .. S c i. 7,12:674-67. 190. . ^ 2ft. SollkoflT, L. J.. J. C ht;rp e n d B. rom<l, "RelttUon Betw een j.;!**;1 I," y c.-*., bestoa and Mcsw Iwhosua. ..... ^ ^ V -A ^ to -a o d N ra l^ m %*>*n s ts a H ;;rs m i. th e thorax a[lc\ /o r f? w f) R tLw .aw a I,, . a later sludy 5 1 uK t o e o w et al showed that, .a ltu r m w m co-uld; >be found to naZve u&u w , regional arid distant l y m p h .nodes, bPhcQ> 12? ` hi.-PfitmW. S., -Histm-y of Ptdm om iry . ,,if s|ir- lt. Mt'd. J,, 8:1020-1020. 1007. A b .>* E It, A.. -T h e o c cu rre n ce ,% ,d nonary ribto.d unci O ther P utm onary It " : ', iH A rW to W o rk c re rtJ. m il. Him., "io ft-'Affi f 'd I 2 * .3 ! 1 9 - m I # 3 0 . ,, ** Mills It G-. "Vulmoluiry Af.besto'ils: Ite-, 7,t P f ft 'w ise," A linrt. M n i., f 3 ;4 9 6 - 4 0 9 . l u M ' Neopittsitt." aua ; ; ; p . r- 81. W agner, 3. t . I ,,:!:.V bcU onm en d cAhs&bnesdt.os"DExinpuosseure In tu t Nmourt-h w estern. Capo -FRIDAY, SEPTEMBER 20, 1973 FEDERAI RgGIfR. v01- 38' N0, U PiiO P'SSEE}' R U LE S - ;. Urlt. J- Inti. Med., i7:S6tt--37l, R3. "Rcisoi t or the Advisory Committee on. A1.(.M <i.u>c3 to the Dirocbir of the IB. B t, ir.X`ipioii. Is., "Two Ca of tmiiiiu!. i! A),.my w if9ictoli on Cancer, ! .v.i '.iter a x p . , ^ to'-A* f m t J }HU!. ,ti. jo d.; 1073. y., .A}. Hmh Hasp. b is., <$*8St--328, i The CdrnaiiKiiioner reeoKi!S7.e/5 th a t it is. ' g3, a>tttotr, I,. J. and . C. Hauiuiona, "Eh* not fWi-aihl) ta eliuiiuttta all sources of , 1A EpIdeniWlogy,: H I. ConuminH.y ushesitos' ciiutiiot with food and diuga. of Kcm.occupaMoual Envisommuitai AsbcHtos 1 m;d In an n|r r . , U' i n w r a i n v , " *inil J . h u b , H e a l t h j s i ! ,, ' is, ia \ ' S . i ` 5 nrrv !n? Tff!n5 rnH [ ,watct .lh buildings in ' li \ - `Epideiatolocy of n J u which food ami anigtj ru m am ifactured, . ,1 ft.,n o r,; Ertdpiioo Ml on Asssoi' and hi (runiy filtering eysiterns used In the >, i n m !,n!il!i's m South Africa iuni nuumfiteiure of food and drugs, and Is . . . . i K >i, 'lorn," An. W.y, Acad. Set. found in tom substances, notably water - J, Jltko. ` amt tald, used in the manufftCture and cho-., , K. C. Haim noiul, A. M, IiriKWxclUB of food and drugs. Neverthe >, w, >1. Nicholson, it. j. sclikott and y, ra :~ m , ` <b>.>u>ak'l Effects of Aabt-m08." less, the Commissioner also recognizes p u t t 'd Sit th o N ational In s titu te s of th a t asbestos libers perform no Junctional v -...'ii. rats, t, fi>73. purpose in talc and are an unnecessary .. . .rati, L. a n d W. M. T hurlbeck, "The contam inant. I t is therefore treasonable vs uX Asbestos Bodies In th e tu n e a t DCd.'in Nserc:,sales in Montreal," Can. Med i . jr,. j ., s s m w - n o a , m a s. ' :ii. co co s, B. T o tte n a n d P . Gross, ratetoM Bodies in- H um an Lungs a t Au- JAMA, m : 371-373, 3065. S "Criteria for a Recommended sta n d - .nl--O raupatioual Exposure to Asbestos." ci- Rvview C om m ittee, National Iii- :.iuu- for Occupational Safety and H ealth :*j-.ul<m No. H 3M `72-10287 (1972), I/, uc3\, J . R. a n d H. E. Ayer, "M easure" cit. of Asbestos Exposure," J. Qcoup. Med., ;'i . ! 1 E E ' to require precautions to be taken in the manufacure oi lootl and drugs, as p a rt of good m anufacturing practices, to assure th a t the am ount of ushestos fibers in n.nv fdod'oF d r 11If la l^UUc^d to th ejnlnim um fcm-ilbie levey Accordingly, tne Commisi.loml{' lnlg*micluded to take the follow ing action: 1. In view of the demonstrated hazard in animals from injection of asbestos fibers, the Commissioner is proposing th a t the good m anufacturing practice (GMP) brrmei filters, is alo. requested, Pimviy, . coiiim m t on ibethoda of quant dm ivo itiwuHsuicnt, size ftinJysis, u u l char- ActiTlsatiutt of partielcTs and itber.,, J* 'essential In order .to develop in,rd method's on which accurate and fa ir compliance can be based, . Therefore, pursuant to 'provisions of the Federal Food, Drug, and Cosmellc Act .(secs. 402, 502, 701, 52 S lat. iO-fi? 1047, as amended, 1050-1051, as amended, 1065-1050, as amended; 21 U.8.C. 342, 352, 371) and under authority delegetca to him (21 CFft 2.120), the Commissioner of Food and Drugs proposes to amend Title 21 of the Code of Fcdi.Tu! Regale tions as follows: 1. In P a rt 121 by amending 121.101 (d)(8) by alphabetically adding to the table a new item and in paragraphs (h) and U> by revising the entry for "talc", to read ag follows: 121,101 S u b stan ces th a t a re g enerally recognised as wife, * '* ' ' 4 (Cl) * * * : i'roduot Tolerance Limitations or restrictions S .uuUiim e, L. M.. "T h e in g estio n o f as- ...fW3 by ra ta ( u n p u b U s h e d .d a t a ) p e r s o n a l . v ..,a;,i!,.iUon to B ureau of Foods, FDA it.i>:itli, W. E,, L. Miller, R . E. Elsasser and 1 13. H ubert, "T ests fo r C arcin o g en icity of . 7tos,".A n':-N .f. Acad. Sci.,. 132:456-488, if. W estlake, G. E., H. J .- S p ju t a n d M. N. ' alls, Tenet-ration of Colonic M ucosa by , .l:s P 3 ftid es. An Electron Microscopic :. in F ats Fed Asbestos D ust," ta b , In * us, ' '3,5,1005 - j. tu m iiig h a re , II. M. and It. P ontefract: , ` Asbt.at.ua f ib e r s -In Beverages a n d \ . tra," Ai, ta*e, 232:332 -333, 1071, ' . , u.n c-i In d u strial Chemicals '"> -i ' >>t Journal .of the , ->j lb '.? . ; . / ". - ' : i M. M. C u nningham :. ' 1 rb . , ui , il..uugh the blgea-- ilu lu .e , .15:352--353.0 . ,n, V . \ , C. J M aggime and ' . " i '1:,to r C ontam ination of ... Drugs, Science, 177:171-173, 1072, . Tui, a e n d A. i f . W rig h t,."T h e P ene- u't.ii of N on-Pyrogen In fu sio n and O ther ..-.svenous F lu id s b y A bsorptive F iltra tio n ," : 4,'s Surg ., 1 1 8 : 412- 428, 1942. 47. R em ington's P harm aceutical Sciences, f-i enteral Preparations, Pyrogens," C hap- .1 82--14th Ed. (pg. 1524), 1970. 43. Schm ahl, D,, "Cancerogene W irkung ai Asbest be! Im p la n tatio n von R a tte n ," sitschrift fu r Krebsforschung, 62:561-567, 363. 49. H arington, J. S. a n d F. J. C. Roe, "S tu d - of Carcinogenesis of Asbestos Fibers and fir N atural F ibers," A n n a ls o f th e N.Y. -liemy o f Sciences, 122:439-450,19C5. iO. Roe, F. J . C., R, L. C arter, M. A. W alters regulations for drags be amended to re quire th at filtration procedures for p a - , rental drugs shall utilize either a non- ' asbestos-containing or non-fiber-releas ing filter such as a membrane filter or, if an asbestos-containing filter is neces sary, shall also utilize an additional non asbestos-containing or non-fiber-releas ing filter such as a membrane filter to reduce asbestos fiber content to the m in imum level feasible unless such a subse-_ tnum tfijjgrjrin^ iden tity stren g th , quality or purity of inn nrodiicr,. ; " 2. The Commissioner intends to pro mulgate a final regulation for talc under 121,2001) as w on dH UllHiUHjU lot- deTer- lillfllilS aspestos fibers m loca-grade tain S^^TOS^W ^T!c^^Ti!?niocnsproposed .below,:as p art of a lepiiblication of the e.niier proposal in which'jib methodology .was specified. The Commissioner co n -, eludes th a t a filial regulation for talc, under P a rt 121 cannot be promulgated until a reproducible and accurate method can be specified for compliance purposes,... 3. The Commissioner is also proposing th at any talc used in the manufacture or processing of drugs meet the specifica tions for this substance th a t will be im posed by 121.2006. _ 4. The^ Commissioner realizes th a t the issues raised in this notice are complex and have widespread ramifications. Com m ent is requested on all aspects of the public health significance of ingestion (8) Miscellaneous and/or general mn pose food tuldi tl ves. Talc (free of asbestos fibers as deter mined in Lil.20). . . Jn chewing gum base and as an am sticking agent in forms used iu molding food . shapes. (ill * * * . . ' Tf,1 (free o i asbestos fibers as d e te rm in e d in 121.2006). (i> *'.'* '* ." ' . : Talc (free of asbestos fibers as determined in 121.2006). ' . 2. In P a rt 121 by amending Shbpart is : by adding se foliawtas new Ecd-icn; . 121.2000 Talc. ... " . ' '(a ) Talc is a naturally'- G ran.'m y ' hydrous magnesium silicate.subject to a prior sanction.for use in coat-lag- pol ished rice. I t is found in n atu ral deposits, th at may be contaminated with asbestos fibers. : (b) Good m anufacturing practice re quires th at tale be free from asbestos fibers to the maximum extent prac ticable. Accordingly, any food or food i J. S. H arington, "T he P athological E f- cts of S u b cu tan eo u s In je c tio n s of Asbestos icers in M ice: M igration of F ibers to S u b - xr.othelial Tissues an d In d u c tio n of Mes- iheuomata," In t. J. o f Cancer, 2:628-638, 67. . 61. K anazaw a, K., M. S. C. B irbeck, R. Ij. crier and F. J. C. Roe, "M igration of Asbes- a fibres from Subcutaneous Injection Sites i Mice," B ritish Journal o f Cancer, 24:96>6.1070. and injection of asbestos fibers. Since adoption of any new filtration require ments may require use of additional equipment, comment on the availability of appropriate equipment, the need for use of asbestos-containing filters as con trasted with filters which contain no asbestos, and the time needed to ob tain and begin using non-asbestos- containing final filters such as mem- packaging material containing talc that is not free from asbestos fibers as deter mined by the method set out in p a ra graph (c) shall be deemed to bo adul terated in violation of section 402(a) (l) of the act. (c) The following method shall be used to determine compliance with this section: No. 188--Pt. FEDERAL REGISTER, VOL. 38, NO. 188-- FRIDAY, SEPTEMBER 28, 1973 ?'t&cr.k^'.yt>r,.-'z:.`- Vi-i--* 27030 - ; -' PROPOSED RULES (i) The various kinds of asbestos are distinguished from talc and from each o ther by their refractive indices, other optical crystallographic properties, and limit for the presence of these asbestos a t least 99,99 percent free of chrysotile "tllterk In tfelft. T'fl&Sft UHUli assure a" asbestos fibers. purity of talc at least 89.9 percent free (3) O ptical crystallographic ch a rac of amphibole types of asbestos fibers and teristics of asbestos m inerals and talc: morphology as determ ined w ith a polar ising microscope (M ethods of th e Asso E xamples o f E epractive I ndices (n) ciation of Of/Icia! A nalytical Chemists, l l t l i Eel., 1970, Sections 38.541-36.543, Substanc nS Estinction Elongation p. 717-721).1 Talc occurs m ainly in the form of th in plates, which may appear fibrous when seen edgewise in m icro scopic view/. B e ta an d gam m a indices of ta lc vary fro m ab o u t 1.575 to 1.590, b eta being very close to gam m a. All of the principal refractive indices of chry- sotiie are less th a n 1.590. C hrysotile asbestos is therefore distinguishable from fibrous looking talc particles in a 1.574 refractive index liquid an d th e o th er five am phibole types of fibrous asbestos fro m ta lc in a 1.590 refractiv e index liquid. T he table of optical crystal- burmphic properties for talc and .the ^ d 'estef! m inerals in su b p arag rap h (3) ohowe i- sfractivo indices w hich a re u 'iy ' if'-m itered ih these minerals,p r t 0'ir, rp- ci sam ples m a y have indics: *d f-rh rr snmpwhat higher or lower. For pi'piled n iv m rn n o n t'- of optical prop-. e r f .ror.-r, in ilto table,:particles iden tified-by this m ethod should be at least 5 nm or longer.- . (2) W eigh out 1 m illigram of a repre sentative portion of talc on each of two microscope slides. Mix th e talc w ith a needle to spread evenly over th e suitable a r e a o n one slide w ith a drop of 1.574 refractive index liquid, and then the o th e r w ith 1.590 liquid, a n d p lace o n each a square or rectangular cover glass suffi ciently large so th a t th e liquid will not Actlnolite.. Amosite...---.. Anthopliyllite.. Chrysotile.. Cfocidolite. Talc., Tromolite. 1.614 1.630 1.615-1.655 1.625-1.605 1. 1 1.663 1.675 .. 1.598 1.623 . 1.698 .. 1. 698-1. 674 1.605-1.685 1.1 1.608 .. 1.619 1.630 1.UH.633 1.630-1.042 1J 1.629 1,635 1.633 . 1.493 1.638 1.504 1.508 1.826-1.559 1.612 1.530-1. 664 1. 1.63 -1.54 . 1. 1.542 . 1.542 1.543 (calc.) 1.54 1.550 1.546 1. 557 1.548 1. 560 1.695 1.693 1.695 1.697 1.700 . 1.639-1.545 . 1. 1.539 , 1 689 ,. . 1.539 ' . 1,589 , 1.639 . 1.57) . . 1.540 nearly- n 1.641 ' 1.69% ... 1,544 ' 1.5 `8 1.591 1.645 -1.61:1 ; ' 1.D99 1.613 1.509 1.613 1.509-1.612 1.613-1.628 1. 1.000. ; 1.616 1.602 1.814 1.602 , 1.613 1.602-1.623 1.613-1.638 i. 1.604 1.612 1.601 1.6X7 1.699 1.622 1.609 1.623 1.613 1.621 1.641 Inclined....................Positive. 1.680 . 1.702 Parallel.................... Positive. 1.023 , 1.631 . 1.610 . - 1.657 1.640 - . 1.052 . 1.617 Parallel,. 1.522 . r-1.667 . -1.55 . 1.555 . Positive. 1.555 . 1.557 . 1.557 . 1.560 . . Negative. " "97~. 1.703 . Parallel or 2 or 3........Positive. 1.689 . 1.680.......... i.r ) ......... --. 1.675 .......... .A....... i.r-1 --...... l.f/U -____, 1.68 * 1 * Inolinoci - Pi XJ 1 1 67 l.i *t . 1.031 . .-I.r. . . `1.628 . 1.630 . 1.630 . 1.63 . 1,634 . r u n o u t fro m th e edge (ea. 18 m m . square) and will provide a uniform p ar ticle distribution, wmars minted hv this m eth o d should rrfeE-Wt UUlowing TJ- fge--rrm.lUva>*.n.(-tf>frtnofrTnTic*.r.i-i,U7.0nr f to .r w a i ci !, m ratio or greater UU w id th o f or less. Count and feSRld t_h_e n__u_m_i_!hor 6t asbestos fibers found in each 1 m illigram as determ ined from a scan of both slides w ith a polaris ing microscope a t a m agnification of ap p roxim ately 400 X. I n th e 1.574 re fra c tive index liquid, chrysotile fibers w ith indices less th a n 1.574 in bo th extinction positions m ay be p rese n t; in th e 1.590 refractive index liquid, th e o th er five amphiboie types of asbestos fibers w ith indices e x c ee d in g -1.590 in b o th ex tin c tion positions may be present; Check the extinction and sign o f . elongation for te n ta tiv e ' identification. F or specific identification of asbestos fibers, make ad- ditkm al m ounts in appropriate refractive index liquids, and refer to th e optical crystallographic d ata in th e table. A , count m ore th a n ipfin aranljtiyilfi tvnog nf ash m m niters and not, more *n4-n. " 3, i n p a r t 133 by adding th e following ne,w, _p..a. .ra g ra p h (i) to 133.6 to rea d as follows: 133.6 Components. (i) Talc is a naturally occurring h y drous magnesium silicate which may reasonably be expected to contain as bestos fibers which m ay be injurious to health. Current methodology cannot as sure the absence of asbestos in talc. Accordingly, any dm g, drug Ingredient, or drug packaging m aterial containing talc th a t falls to m eet the specifications of p a ra g ra p h (c) of 5 121.2008 of th is chapter aa determined by the method set out in th at paragraph shall be deemed to be adulterated in violation of section 501(a) of th e Act. 4. By adding th e following new p a ra g rap h (J) to 133.0 to read as follows: 133.8 Production mid control procodure. ber-releasing filter may be used in the m anufacture ol a p arenierai ctrug enteral drug ingredient unless it is not possllile to m ah'tilacturc th a t drug or " ' A " g<> r" a filter, if use of such a filter is required, an additional non-asbestos-conlainin g o r n o n -fib er-releasin g filter su ch r.s a m em brane filter shall subsequently be used to reduce the content of any asbes tos-form particles in the drag or drug in gredient. Evidence fo r red u ctio n r-Isrfi bo based on the use of the m ethods de scribed - in "Criteria for a Recom mended Standard-O ccupational Expo sure to Asbestos," R eport of Review Com m ittee, National Institute for Occupa tio n al S afety an d H ealth, P ublication No, HSM 72-10267 (1972).8 Use of an osbos- l a Jm m ; m em brane filter is l|Srai!S!!5? m ^ ______T_T f r y * .W 155 c hrysotile. asheatna fibers PO fr milUg'rani-tilide constitutes the maximum. of a uonriisbsfe^B ffR H raiS lllMbf'ane <J> tiM of asbestos-containing filters: Copio m ey bo obtained from : 'Association of Officiai A nalytical C hem ists p.O. Box 840, B en jam in Franklin S ta tio n Washington, DO .20044 . F illers used In the m anufacture of a parenteral'drug or parenteral drug In gredient oliali n o t release fibers into such product*. likLJ>,r,bcr,ffLS-iNinKatnJmwv- fU Coplea tnn.y he o b tain e d fro m : Super biteiK ent o U-S.-G ovornnientPrintingO i8eo W ashington, DO 201011 . ____ :___rE .ir.-r V O I. - v-1 tilir I'ilUU 'ca l'u-oi,!,-' may, on o rb e fo n j j , , . .. r ^ . l a '. l U H a w ith th e Hem ,m m ' - *- '< J!d D` m Admiiiiiti`ation j: 86, 8'.*00 Vi lu 1-8 Lnne, Rockville* ;,m ^Oi'.'i'i, vuitU n comments (prefer-' i i h -i mmitupllcate) regarding the m - m u onvl tilt,* Commissioner's proposal, t ' ' `i v i'is may bo accompanied by a" ,, .o. -ndiunor brief In support thereof, k * pc-lion, I.;i.kp.iitunci inlovamijou re - fv.-K-tl to M tills proposal, and comments } >1 in:,y seen in the above office t* uni t corking hours, Monday through uhby .. . \ l.biled September 24, 1973. . A . M . SCHMIOT, Commissioner of Food and Drugs. jhii Doc.73-30711 Filed 0-27-73:8:48 am] Port 71: o f the Federal Aviation llpcm- lutioim Unit would alter several v f i t Federal Airways la the vicinity of Ohlfftso, in., dim to the planned deoommi^-. sionhig of tire. NapervlUc, ill., v o a , ' " Interested persons .may participate jn Die proposed rule making by. submitting such written data, view's or arguments they may desire. Communications should identify the airspace docket num ber mui bo submitted in triplicate to the Director, .treat Lakes Legion, AttentionChief, Air Traffic Division, Federal Avia-tlon -Administration, 2300 Fast Devon Des Plaines, III. 60018. All communica tions 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 changed in the light of comments received. An official docket will be available for thence via IHT DuPage s-kVi -; -v- ru'JM ;, r.u l Osh! o;h . vvh, py, % M) ivdf3! >. to Oi;hLc. h. T iiit.'. iicrviUa V o ii win l.c d- elwm-a about Juno of Ib7i di,.-; t u . ;.t. creased cost of lease.rchevul oi i " in . pftrvfile site, and the f nt uw u;-.rrm:r- tal effect th at buiUjm.i plaiiarni ioc the vi cinity would have on fi.g NAVAID. The DtsPago-VOIt wlU he ire:;ir:(i;:y piefescsd so tliiit it can serve lix t ; ; T struc- t-m-e. Some of the- snew./m in tills vicin ity would be realigned via DutTs.e in heu of Napcrrlllo. This am endm ent is propasci under the -authority of tec. 307(a) of the Fed.n-H Aviation Act of 1958 (49 T ),ac. 1348(aV)' and Fee. 6ci of the D cpartrccnt of Transportation Act (49 V.B.C. 1655(c)). Issued in W ashington, D.C., on Septem ber 20, 1073. - Social and Rehabilitation Service [ 45 CFR Part 221 ] FAMILIES, CHILDREN, AGED, BUND OR DISABLED INDIVIDUALS ' Service Programs; Correction FR Doc. 73-19242, published a t page 21872 in th e issue dated Monday, Sep- 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 informnl docket also will be available for examination at the office of the Regional Air Traffic Division Chief. The proposed am endm ent would: Charles H. Newpol, Acting Chief, Airspace and Air Tragic Hides Division. fFR Doc.73-20703 .Filed 0-27-73:8:45 a m j [ 14 CFR Part 75 ] [Airspace Docket No. 73-WE-10] '".'4 t&nber 10,1973, is corrected by changing- 1. Realign V-6 from Cordova, 111 via AREA HIGH ROUTE 1, The num ber "233" in item num ber INT Cordova 087T(083M) and DuPave !*?, f, tile Preamble, fifth line, to 111., 255T(253,)M radials to DuPage' Proposed Alteration From the INT of Chicago.Heights 111. The Federal .Aviation Administration 2. Tiie code designation "221.0 ( a) ( 3) 358T(356M) and South Bend, Ind.'' (IAA) is considering an am endm ent to (-) nx item num ber two of the preamble 271T(271M) radials to South Bend. " P a rt ,5 of the F ed eral A viation Pmguln- 'h l i n e ,t o "221.6(c) (3) a ) " ; ' 2. Realign V-8 from Cordova, 111 via tions th a t would realign a segment of . 3. `th e code designation "2116(a)(3) INT Cordova 087T(083M) and Joliet J - 938R from Reno, Nev., to Maple, </" m item num ber three of th e pre- III, 291T(289M) radials to Joliet ' oaiii. . d looub. line, to "221.6(c) (3) (hi) 3. Realign V-9 from Joliet, 111., via INT Interested persons m ay patic-inate in i '11-- cede designation "211.6(a)(3) Joliet 329T(S27"M) and Milwaukee the proposed rule making by subm itting r,`j \ 'at i'r.nli.nfenutomfbfeifrfifl.oCuter.)o(f3)th(evipi)ream - kWeses.., 20a.T(207`,M) radials to Milwau tshuecyh mwaryittdeensidrea.taC, ovmiewmsuonricaartgiounms esnhtosual-d-: ` ''j. Je desi a h ion "211.7(b)'" ,in 4 Designate new VOR Federal Airway . identify the airspace docket num ber a n d 1.. nve ox tire preamble, fourth V-9 west alternate from Pontiac, m /fa be subm itted in triplicate to the Dii , - uj " 21 , C i ) " ; . ' . INT Pontiac 345.T(343M> and Milwau tor, W estern Region, Aft ntion: Chk'r i a <. o ti-'-:gii,.tion "211.9(b) (3) " kee, Wis., 209T(207M) radials to Mil An- Tx-anic Division, K m m al A vioH -n j * i" r her faexen of the preamble waukee. " v > . A dm inistration, 1500 n ,, imuh"! >, / m . to -2319(1)) (31", . " . 5. & Realign V-10 from Plano, 111,, In vard, P.l). Box 92607, \ i ... r - X i ' '--r code designation "221.6(a) (3) " tersection. direct to Chicago, O 'Haro, 111. Center, j ^ s ' Anxc-kx c -'-i' . '.o-V If. Uw w - d s of issuance, num ber three h. Delete th a t portion of V-1Q. which communicLtions y t: Rived i-u V<* . lies between Plano intersection and Niles, Ociobt - 29, 1973, Will be ,icf: , f f . . ' . ' S t S i ( S ( 35 v (aH 3) ifaeIf>iirst 111., intersection. fore action is taken o r Um m g : 8. The num ber "8" in 5 221.6(a)(4) 6. Delete th a t portion of V-10N which ameriihumit; The pi-uimxl , .-xh.r-,;..Tin. E ^ S to!221'6WH> lies from Naperville via Neptune Ind this notice m ay h., c:.-..oa,a in P K & jT intersection to South Bend. " or comments received. " 9. Tlie word "secured" in 221.9(b) 7. Delete V-97 from Chicago Heights, A n official docket will be available lo r : *5), fourth line, to "secure". 111., via Joliet, 111., to Woodstock 111 exam ination by In tetcsted persons a t th e intersection. - x-euerai A viation A dm iiiistm tioji, office Approved September 2 4 ,1973. 8. Realign V-97 from Northbrook HI of the General Counsel, A ttention: Rides _ J T hom as S . M cF ee , direct to Janesville, Wis. Docket, 800 Independence Avenue SW Deputy Assistant Secretary for 9. Realign V-100 from Rockford 111 Washington, D.C. 20591. An informal Management Planning and o n S r u f 1 via INT Rockford doexet also will be available fo r exumina- Technology. (290 M) raMdi)als0.11(1 Ro.rthbroolcs 292"T tion a toe office of th e R egional Air Traffic Division Chief. !FR Doc.73-20720 F iled 9-27-73:8:45 am i 10 Delete V-116 from Joliet, 111., to As p a rt of this proposal relates to the Neptune, Mich., intersection navigable airspace outside the United DEPARTMENT o f . 1J-Delete V-116S from Naperville, 111., states, this notice is submitted in con t r a n s p o r t a t io n via Grand Beach, Ind., to Keeler, hid sonance with the ICAO International Federal Aviation Administration 12. Realign V-177 from DuPage, III., ofcaudai ds and Hecoimncnded rractices. direct to Janesville, Wis. A pplicability of In te rn a tio u a i Bi-uud- [ 14 CFR Part 71 ] 13. Delete V-218 from Rockford, 111 ards an d R ecom m ended P ractices by the (Airspace Docket No. 73-GL-44] to Keeler, Mich. Air Traffic Service, FA A, in areas outside VOR FEDERAL AIRWAYS 14. Realign V-227 from Pontiac, 111.,, dom estic airspace of th e U nited S lates Proposed Alteration direct to Rockford, HI. is governed by A rticle 12 of op si /- 'm a l l to th e Convention on WW,!.,,,, mal . 15. Realign V-429 from Joliet, 111., via Tederal N a t i o n A dm inistration INT Joliet 351'T(349M) and DuPage, Civil Aviation, wliich p e r t T u : t-ito AA) Is considering an am endm ent to 111., 185 T(183M) radials, to DuPage, establishm ent of air navigahen n. ufics and services necessary to ixvuioun j tixe FEDERAL REGISTER, VOL. 38, NO. 188----FRIDAY, SEPTEMBER 28, , 973