Document DDk6dyGKD3Ra5jOL2dg2aQqyo

FROM J. V. HOLDER PITTSBURGH OFFICE -Vir ______ ____ T0 R. M. JAMES 20 AB PITTSBURGH OFFICE - 6 AB 1988 SEPTEMBER 01 RE: RECORD RETENTION - ASBESTOS REMOVAL/DEMOLITION Any closed contract involving the removal of asbestos will be kept with the Procurement Department records at the Records Storage Center at Boyers, PA. The contract shall be identified with a notation that after the retention period of thirty {30} years, specific approval must be obtained from the Procurement Department prior to the destruction of the records. All contracts involving the removal of asbestos are normally written by the Pittsburgh Procurement Department. However, by copy of this letter, all of our plants including subsidiaries are being notified that if they do write any such contracts, they must make arrangements for the extended record storage period. J.~V. HOLDER JVH/mk cc: Domestic Location & Subsidiary Procurement Mgrs. P. R. Atkins - Pgh/19 AB -H^Pr-Bclk Pgh/6-ftB---------W. K. Benefield - Pgh/20 AB R. F. Burnos - Pgh/8 AB C. L. Carleo - Pgh/20 AB A. L. Doner - Pgh/20 AB G. R. Farneth - Pgh/20 AB H. M. Goern - Pgh/29 AB M. W. Leeper - Pgh/20 AB T. G. Poliak - Pgh/20 AB R. G. Quaintance - Pgh/20 AB L. L. Rippey - Pgh/6 AB L. M. Schneider - Pgh/6 AB R. E. Yester - Pgh/20 AB J. R. Zokaites - Pgh/20 AB (PDA 3&4; I 0 ALCOA C35793 1278 SF-4663 iREV as.?. .t; IK // DFAL/vS Ivl TV ft i 0 ts TO s/r / !n' y/of 1 ^ 1 / >/: ?/2 O /? l~ b / -i, /? X. Ihh' ?/*&/ 7$ y^o/7? (e ft /[ 8 2 f'A A/21 tJ \f l? C x> /) T/: tr'so J ... . `f Cty/fl'"-' * , C/ y^r ^ S fcv i-ro\ Dot", 0^ /^Lt^x t-d'O^ Sosrvt * <~ *o> * * f* "^4 6; /VLjf, cc c;C) Sj'*tJ.J (Ijfrt--,r` ` t/C Cd*xy/ -*f^tc pitted'**^ **tiJ ^ <U,e2yi'/ . /< /V* c: f 4-7*/* *G * s-S J y- "i*J ^wJvf-A' d>AI~>4 1 Sy^ A/v Mt-fkad cL&ih e i/g. ls& ^*-0**) 7jl/? 2,^ J Aw, <-< Xj CSvJtx . f~ i) Ciy y CrJ s' P ^'SsC+r l Rpffoveo fh Bel To jl9$P<6*TO(l'l PRo-r at-TiOO ((ncU~*r^, Provi <L4 ) Sties Ytil^ ^ -t vj ,.> ^ y 7~ / O C-r * J $ /?r/V/Vf / /v ^ t.'/ />- ^ r e* ^ <f >>*/ r //>:;< ^ TV *v -'// 7 ' v ," \: (* t* 7 * -' >/ i * *f **'- ^ v $j**U~*'r***<^ \^, i-*S SV & $ T/T^T \ /z*r> '3 S'ixr; r* f ^^**' -y ^ ^ tv*j (* ^y>- }M& yiOrJ o * ij ,j /Je c r ; /4-/P '/ -j ! /j Qc$ 7os - Co**Tti* aJ /*/ tJ"t $ o? P/OI r*-~' P r < <J t-if>vCCci`<y sy{ b/ ySi^ 'j'c^<'ly ^.CJ 1" a(f yJ f) s / i ' - ro J R Miclx J. . J*{js('{ / pfvev~\ < i) ^ ^ b+t)iP-K`.^j J C35793 1279 /b'i R 5 f* J R K*t ^ t*** f V f -- (bf4-- S* is ^tfeJoRitS A /<--* 2 Pt <****.Ux&v Put/divfSt ( 7 M **'4 T tfovt'Xs*~vi , /&tf\ J 4w.-.. * copy to Dale Huddleston, 12/15/87 /? S __Cf S>tOdr/^'*c>Ciiia '/ /? /Os /-g r S'o it Jr*c*'jnt_^JL_d_ G-<-r- fy . S-t f~ />i 1 3 F> -tSTTT**~r^---------- 73 . ji i tx i ^*r~ *> C J C eyO fx c/ tviV/rfu' C'Y ( ~f~tc f J k**)____ yYZ_ ^- R ilk. ujti fZ <r,a^i> ^<v_i_//_______ j-_____________ /Y/^y gjC 5_f7JU?.___t-t/tf X ja.^ _ _x__o j~4r / tf-g) %>__ _j 4/ /'Jf , a-r- --r-'- _ /cj^y L A 77// 7a5 J -/A* %*Z1-. //7 yw/c/ &0'S -fV/r/e-k. ca -J_____ 6. f^nk. it n//// 7^P* . <Vj //.. 2ya,'(/i*/a^ 4 ii /*) //a '70_ " c 6/>k * /&%/ AK&/~ ^/tsHCa-r' - G 6 l&4%r u----------------------------- --------------1---& /ja IT ; /o /?. /IMU-i- f& _ ZV> /a 7^a___ \ -/ ' &' ,'^C/ y ^</e i~/i j *i s-r- a If V/'-V ; _ur-.o* / A e uJ 7L0 >?VT ^ .To-' r 79 S3 / "/if (_P (0 (, *; Jj.ttaf tJ/ ^^rjZ, 'W< t,/'//y,___^_^<,t,^,__>r "f~ '5 >y~ / * '' P'pT- p'7. ^<^-t--` * '-'X. 1 .. ^V.. -S ,-f ^Tm.O'n C ZU /X 11 ' -^7 c/,' Cr/^p**' a / . Q_ 3 , /7 Q f f c > > ' ' J ^ a f-ytrt a. T.S^ C. Cf.t j i ct (; /< c-*~- '^-*t i A A CGj H />-y,is s AA.> / /16? /2{/<c ?_ < _?!_:..Gi-i-ti____ (Ji J h T cj^u^ct^- t S //(, ^ __/'' / /? Z . ,, Ov- XrYiflpz f* -3, - ^<2 >6V ^CA t>/. -*1'&.. Z^^i4c/^/ / /c C ^^91C g(/ tyj { L~A ^f f//A 'J-'( rvrrc^: / .7^> '; "I ' '-??.>/ lA/&/s ft - ^ ,^v O^KA. ...^T$ 7 ^ 7 / .... /e . ___________ _ . ____ . "j. w lOi/v U7L,,, c-v *~r 'i'/'u ^itZ .*i...oAHjl__._/5r IH -Kfc.k/ Tu/_ ?a ; vT^/cc___ rj/ ? ^ :_.i^isr5_.... _ h ^OSJ^jfio/?jj"A /eHi' c. , ..^Vjw*ri__ 2>~us.._. ..._______ C35793 1280 _& 0-^^ 4 NIOUJ '^t . OSH4 "^4-- 1- $^-24.___ ^ XZ1'' .*-* S' A(LJ,J Or.-TL-x..^ D*4 ^?>c o <vi/ee. (/**7A F ~ S O'S" 5 & l, 3~-fr l> olt. iX^>i ^ > v __________ -3,/->/s>y ^.:___ Ac &/tf /i&o____ J-/ 4v^> 3^ /ccC o-axxz/sdf o.flj favtxl* 2_ 0`X) jj-_____ Al* r/.r _________ --fa hAi'fbt/. h- y________AJ) A H- CftL** fytttrw'-j" / 9 7t____ __________B-i____QJLtLQ___^ulsi*___v 4 AjJ, t/ #/+>* ^ h-r ttrn y, / 1 > yf? /L J+ CA+jt'ftLi A~ IfrJi f fj J V- ? C?/C ---------------------------+~cL<t.Aly } rv.cdtjfg y -TZ^______ ^ <#_____ CjL^mxcaJL____ _______________________ t*>/y*^____ ___ Q-J^^ 7 jj4L 72_ C35793 1281 J./-L_Csn^t-JM ST-il>*_ p 6 Gc.{ 4 ___ /^Ai &** J* A fJ ^ if*. "/A jt^ wjL^-t d, > u / iM / d-L~*jj___O iC___ f-*HjV __(*y*J__<^.__ ty*t-LeJ'^uf>* ^ O c 7* Ct 3______'nS*" ?*jXv, tl+r <?S TJi$ U> *'*MP j. ,w> Mjj~o^ Oyl&rvJ^* . 23... 4 s______ A-*na^y 1^-*'^ )rt*fer'f ^jrr ___________________^.i *- /^t?4<^-j^ ^ ^///w y/ru. Si+r~*2tjt * ML 7^r, 7* ^ /'?**** o^i. ^> w i Z+ hi t-tf> fa*t T/'oV^ i*/ df / i dF^k /^a.4 ^ ........... ry j V"^->-n l.^ f* </ ....... _ ___ ___________________________________ ._/___^ke-.^.f______J^j/L <^ywy/ ^___K/Or.4__/7__/I t . fjy ^ - ' ? <r 4i * F*i> no __ Uy _ ^"f_ W -------^gilrt *-------*-- r'^* ,------- --------------------------------------------- ^ fo. 70____l^yLLj^ A g frw// k*___*4*Lff44rf ^.!___f<^/Mm___.^ /^ , C35793 1282 i Aluminum Company of America ALCOA LABORATORIES 1 Q d 0 1 V* *< u -< c 4 V 7= JL ' j *l/> t 4___ v. K s h J vl *j l. s* o iiL ^ d? J V N. ' N t si <v o \. >* V- u t* <j N K V *V Xj I X* 0Q 4i ** ^ v. *> ' 0 a W u> V w 'At > 0 `-J * _L 1 Vuu V Vj u k N V N * "> *- . V -* v. ** N ri X V) <o \J o N <o J u S > b 1i F? Or s i/ <o 6^ 1 >VoC ** * N. vs| `1 r* u --^ 4 h 5 :!__ u -Vj :l ^u sk M vJ s 0 :' . -? 1 * i S X 1 r? Vs 51 aJ Vi u _s V t- 4 0 VJ > \J (J V .. 0 . j ir U ^v> ^. 1 h 14 nV> i L, 'o *9 Qc o& CO >3 >8 O' 0* vi sa O' rx <r r* w (S O* 0 js V **v > <n. %-> r* N rx VT* f^. *3 rs j. *> O' O r' QQ S' tJ- o xs O' V A V V 7< N* *V \t rJ (. f\ v> vc Vi % a \p 5 V 5 n . (V Vi \ j s> ---vt 'X vj V J it 'ij C3Ji79C1 12.83 a im ) o trc t m i*o * jl _/V__ v . 0 p AiJL JI &.t.u Qji.Lt- . A/ > lj Q. <L<*tYi J. T tjl'Jj'fri isp ~ic /fyT'i' 'I--* ^ *U / fj Lj-h,J , cbjtf/<Jj J^n. P i C/, '/L* 4j*Ifr^J- / ^ & u - tc,~> \. ___.1 !_' C i- J*d jis-.-. u. JLJ\isL- rj-L^Ji --., f /,^___Az * q > Ay >!/ h^V.tia <^S /fe4,lc*)j 'LL, ; , r., l? ^8 -j ' . f-*t^ ' / /y . ^CaJ~.. -- / "? J Z> cU r~t.frrp_ fi*r*>L>wt-ft. ___t* s L*, a~\___d-'** j -1 ^ _<s_><<. .4\ .. `2L.. __` .VJ l.M . y* ^ '/ _jnr <i_ _fi=rfeu=^>//...... .,-4 ___/ 9<f* __/*?<40*-*^*^ t(if~i / 4*iu.-<___ L'^lf^. j^ 4w^__i^ ibeJ~V\________ /.?_ <v>r *<?_ - ^__/ 5 ^ ^ t?i_w\pL^ jlA frc *7/ 7i,,..^r _ ^y~p.r C-lr~`'*^As'\ J tT., 4-4-i-v^ C-frvt J ( c4v /' CjLjt~lus^_ .t L*.< rir <V J-Z-VyJ HtV.'" S 6' S ''- '* f s- '<..<: ' cP c*~" X -'..i' / 5 - , "4 f d- ! 1'f *"1 1/? /JV J njrtk j-/' _.><\>/ ft, rjUS.-i (_~t -L- -s^. f^Jf^') . ___/>"^'i' _________ (^) ^ S-t'.A/tt:; (" / 'z ( v As -j.t C A .:.. <^`',L'^`,'y ~u 1 i-'4 1 I' / ' >- a S -fityy<L^o/Ji\l (Jt.l!.J ^iyO^t, i >/ yp^, ,l : I,:!,) rJ- -rt'-'--<-< _***_' ' Ar^i.. _______ . J^) A' ^1.. ,; : ^ . . _. . . I^J'Lr'.f. ...-l*j/. w/^/v/yrA- _...... ........... ......... - C35793 A2&4 . ...,- ffe^>. TT -' *>;','* .Sits > -l**.' -... * :V*v.{t,\ r- -;'v. ^ /ff.aT--t *<._' f'4 r.t . __ ^__ /-f <Lfjjy~s_ . - iT i ^--yL*/l--tLx^A. -----/-.i A-+.J kt+n xi/ c*ns<6-J *-*\ _ *~-in/z^, s -----j**-rf-t'/*^ *.?(? /^_________ <*Wl------------------tLu.'t ^ c+Y&L^l____/Li^al---i^i J <M?^n Jt.es *-**-* ^*ua* ______ C*~n'bS /'V'hl iLi^mJ___________ _____________________________________________________________ _ CM+u.f' l^tf/t/ CrfW jLru C^nJZ.tfjLA Of fcfcU Ote. f rc_ $LC4vitm^Jfj___ k^iSbLd >W /f 2f*' *J J/-S PJttJ ./ t/l01H Mx+\X __Jz J^k^jJl jtA __^ <-*. jru.sJ - a.x <rf j/1J}!l) A^ _^~__a/ _/f 1^ . \ ./^i.'^ s~*rA ^ kji-xci :/-, tr-l^'j. ru.lt. /<4*. yii^isA ^ " ^||/f l {jf-~-' cJ t/' /J0 ^ihrjjri, j 7 /*/<,> C^,r .flHj/ft L-^t--ntn-Z - _PJii_e4^t-ir^n--yr^fclllJLoi. iiki. ..... . --------- C35793 1285 CjPjtrf/-s Pf ^ r^ Federal Register / Vol. 48, No. 215 / Friday, November 4, 1983 / Rules and Regulations 51087 ' As provided in 29 CFR 1933.22. the 24 Stjtes with their own OSHA-approved occupational safety and health plans are expected to adopt a comparable standard within 30 days of this publication date. These States arc: Alaska. Arizona. California, Connecticut (for State and local government employees only). Hawaii. Indiana. Iowa. Kentucky. Maryland. Michigan, Minnesota. Nevada. New Mexico. North Carolina, Oregon, Puerto Rico, South Carolina. Tennessee. Utah, Vermont. Virginia. Virgin Islands, Washington, and Wyoming. Also, in response to the emergency conditions faced by exposed workers. OSHA is stepping up its enforcement activities in targeting workplaces where asbestos is handled. The temporary provisions that are being added to the existing asbestos standard prescribes the major components of an occupational safety and health standard, fn general, most of the current requirements remain unaffected by the emergency temporary standard. However, compliance with some requirements will be triggered by the new exposure limit of 0.5 f/cc instead of the former PEL of 2 f/cc. For example, requirements such as change rooms remain unaffected by the ETS and the trigger level for change rooms remains the former PEL of 2 f/cc ( 1910.100t(d](4|). However, the ETS requires that where concentrations may exceed the new PEL, the employer must post signs indicating such locations ( 1910.1001(k)(6)]. OSHA based its decisions concerning appropriate provisions for the ETS on its determinations of the kind and degree of protective action needed to protect against a grave danger and the feasibility of instituting these provisions during the period of the ETS. Under section 6(b) of the Act. OSHA will shortly schedule an informal rulemaking hearing on the proposed permanent changes to the standard. OSHA will also propose other revisions to Ihc asbestos standard that will be explained in the separate notice of proposed rulemaking. Application of certain provisions of the asbestos standard to the construction industry will be raised at that time. OSHA anticipates that this notice will be published shortly. OSHA is now accepting written comments on those issues raised in the ETS which are relevant to revising the permanent rule. The Secretary must promulgate a section 6(h) standard no later than six months after publication of the emergency standard. II. Legal Authority and Background A. Lego/ Authority Section 6(c) of the Act provides for immediately effective emergency temporary standards in certain circumstances. The Secretary has the authority to issue such a standard, without rulemaking, "if he determines (A) that employees are exposed to grave danger from exposure to substances or agents determined to be toxic or physically harmful or from new hazards, and (B) that such emergency standard is necessary to protect employees from such danger." 29 U.S.C. 655(c)(1). Thus, the danger must be "from" worker exposure and it must be "grave," not merely significant and the regulation must be "necessary" to address "such danger," not merely reasonably necessary or appropriate to provide safe employment, in addition, as in section 6(b) permanent standards. OSHA may impose requirements in the emergency standard only to the extent that they are "feasible" within the meaning of section 6(b)(5) of the Act. The Fifth Circuit has emphasized the importance of the severity of health effects in OSHA's consideration of whether an ETS is appropriate: .........the danger of incurable, permanent. or fatal consequences to workers, as opposed to easily curable and fleeting effects on their health, becomes important in the consideration of the necessity for emergency measures to meet a grave danger." Florida Peach Growers Association. Inc. v. United States Department of Labor. 4898 F.2d, 132 (CAS). OSHA also has interpreted relevant judicial decisions to require that its evaluation of the gravity of the danger and the necessity for emergency action must be made in the context of actual workplace conditions. B. Background 1. Events Leading to the ETS. In [imp. 1983, OSHA received a petition for an TS from the International Association of Machinists and Aerospace Workers (Exs. 84-244). Subsequently letters supporting this petition were received from 16 other unions (Ex. 84-284 to 84294. 84^3S7"lo 84-391). The petition requested an ETS to reduce the~PEL to Oil f/cc, to modify some existing work practice requirements, and to require other protective provisions regardless of exposure level. The main reasons set forth in the petition and supporting letters are that continued exposure under current workplace conditions constitutes a grave danger and that delaying remedial action until a permanent standard is promulgated would cost large numbers uf currently- exposed workers their lives. OSHA shares the genuine concern expressed by the petition and letters from unions representing thousands of employees who are directly faced with the threat of asbestos-related disease from continued exposure. And OSHA concludes that failure to issue this ETS may cost a number of exposed wotkers their lives. In August 1983. OSHA completed a comprehensive risk assessment based on numerous human studies w hich estimated the number of excess deaths from the three major asbestos-related cancers, i.e., lung cancer, mesothelioma and gastrointestinal cancer, at the current permissible exposure level of 2 f/cc and at various reduced exposure levels. OSHA placed this document. "Quantitative Risk Assessment for Asbestos-Related Cancers", in the Asbestos docket in August 1983 (Ex. 34349). OSHA subsequently revised this document (See Ex. 84-392). 2. History of the Asbestos Standard. OSHA has regulated asbestos since 1971. A 12 f/cc limit for asbestos was included in the initial promulgation of OSHA standards pursuant to section 6fa) of the Act, on May 29. 1971 136 FR 10466). In response to a petition by the Industrial Union Department of the AFL-CIO, OSHA issued an ETS on asbestos on December 7. 1971. which established a PEL of 5 f/cc on a timeweighted average basis and peak exposures of 10 f/cc. The current standard, promulgated in June 1972, first established an 8-hour . time-weighted average PEL of 5 f/cc and a ceiling limit of 10 f/cc. the limits were intended primarily to protect employees against asbestosis. and it was hoped that they would provide some incident.il degree of protection against cancer. Effective [uly 1976. the TWA limit was reduced by the standard to 2 f/cc. This limit has remained in effect since that time. The standard also includes provisions covering methods of compliance, monitoring, medical surveillance and housekeeping. Court review of this standard upheld all major provisions, but remanded two issues for OSKA's reconsideration. IUD v. Hodgson. 499 F. 2d 467 (CADC 19741. These issues were whether the July 1976 date for the 2 f/cc standard should be accelerated for some industries and the adequacy of the 3 year retention period for exposure monitoring records. Subsequently. OSHA increased this retention period to 20 years (41 FR 11504) and the acceleration issue became moot. After reviewing the then available scientific data, in October 1975 OSHA published a notice of proposed c^'286 51038 / Federal Register / Vol. 48. No. 215 / Friday. November 4, 1983 / Rules and Regulations rulemaking to revise the asbestos standard because OSHA believed that "sufficient medical and scientific evidence had been accumulated to warrant the designation of asbestos as a human carcinogen" and that advances in monitoring and protective technology made reexamination of the standard "desirable." This proposal would have reduced the time-weighted average to 0.5 f/cc and imposed a ceiling limit of 5 f/cc for 15 minutes (40 FR 47652). The basis for the lUZipropcsal's reduced permissible level of 0.5 f/cc was OSHA's then current policy for carcinogens that no safe threshold level was demonstrable and therefore, the Act required OSHA to set the PEL as low as technologically and economically feasible. This noliev was rejected bv the Supreme Court in the henzpnp decision [IUD vs. API. 448 U.S. 601 (1900)). OSHA limited the proposed revisions in the 1975 notice to all industries except construction. No hearing was scheduled on the 1975 proposal. Also, although OSHA announced its intention to develop a separate proposed revision applicable to the construction industry, no such proposal has been published to date. OSHA is basing its present decision to issue an ETS. and to propose revisions to the permanent standard covering all employees, on information and analyses which postdate the 1975 proposal. Therefore, this ETS marks a new regulatory initiative, related to. but not part of the 1975 proceeding. On Way 24. 1983. OSHA consulted the Construction Advisory Committee for Occupational Safety and Health (CACOSH) concerning applicability of a new asbestos standard for the construction industry. CACOSH endorsed OSHA's position that changes in the PEL made for general industry should also apply to the construction industry. OSHA is also including the comments and data received in response to the 1975 notice in the record of this proceeding, with the understanding that some commenters may have changed their positions based on intervening scientific developments and policy shifts. In the decision to issue an ETS. the Agency has reviewed this regulatory history of asbestos. However, the Agency bases the decision to issue an ETS on the actual emergency conditions which now confront exposed workers, on epidemiologic studies that provide data to make numerical estimates of risks and on interpretations of these studies using quantitative risk analysis. 3. The Rulemaking to Revise the Permanent Standard. The 6(b) rulemaking initiated by this proposal is intended to be limited to the revisions made by the ETS and the additional proposed amendments raised in the notice of proposed rulemaking to be published soon. The major subjects of the 6(b) rulemaking will be: reducing the permissible exposure limit, revising the definitions of asbestos and asbestos Fibers, reassessing the methods of compliance to achieve such limits, revising the provisions regarding respirator selection, revising the sampling and analytical method to improve reliability, and adding a training requirement. OSHA will also raise issues regarding the application of the permanent standard to the construction industry. As previously stated. OSHA will soon publish a separate notice of proposed rulemaking to further explain these issues. lit. OSHA's Rationale for the ETS OSHA has determined that prevailing conditions involving worker exposure to airborne asbestos dust justify the promulgation of an emergency temporary standard. OSHA estimates that approximately 375.000 workers are exposed to asbestos at various levels (Table 1). ranging from a high value of 20 f/cc to below 0.5 f/cc. OSHA has estimated that under current exposure conditions asbestos-exposed workers face an extraordinarily high risk of contracting asbestos-related cancer whether the risk is computed over a working lifetime of exposure or for exposure periods as short as fi month*. The average excess cancer risks for all workers exposed above 0.5 f/cc using available exposure data and relying on the risk assessment are estimated as approximately 196 excess cancer deaths per 1000 workers for 45 years of exposure. 139 deaths per 1000 workers for 20 years, 10 per 1000 workers for 1 year, and 6 per 1000 workers for 6 months of exposure. OSHA believes that risks of these magnitudes, taking into account all relevant considerations such as total numbers of workers at risk and quality of supporting data, constitute an emergency situation which requires immediate response by the agency. The Act states that when certain statutory criteria are met. OSHA is authorized to respond to an eniargency situation by issuing an ETS. The two pronged statutory test for an ETS is that (1) employees must be exposed to a grave danger from exposure to substances or agents determined to be toxic or physicially harmful, and that (2) an emergency standard is necessary to protect employees from such dangers. After evaluating all the evidence available to the agency concerning the severity and magnitude of the risk of asbestos-related disease to the current asbestos-exposed working population, comparing these risks to other occupational risks, applying relevant policy considerations, and reviewing all relevant judicial decisions for guidance, the agency has determined that both prongs of the statutory test are met and that an ETS should be promulgated. For purposes of clarity, the discussion is divided into two parts. "Crave Danger" and "The Need for an ETS." OSHA believes, however, that the factors which indicate that a substance constitutes a grave danger arc related to and overlap those which determine that an ETS is necessary. A. Crave Danger OSHA has determined that the risk to workers from exposures to asbestos at conditions that exist in the workplace pose a grave danger of death from cancer and of severe disability from the lung disease, asbestosis. In making a "grave danger" determination, the severity of the disease produced by exposure to the regulated substance and the magnitude of the predicted risks of disease must be considered. In addition, the Supreme Court has suggested that a determination of "grave danger" indicates a situation where the risk is more than "significant'' [IUD v. API. supra n. 45). OSHA has applied that analytic approach endorsed by the Supreme Court for "signiRcant risk" determinations in evaluating the gravity of the danger faced by asbestos-exposed workers. The Supreme Court gave some general guidance as to the process to be followed. It recognized that while the Agency must support its Finding that a certain level of risk exists with substantial evidence it also recognized that its determination that a particular level of risk is "significant" will be based largely on policy considerations [IUD v. API. 448 U.S. 655. 656. n. 62). OSHA believes, therefore, that its determinations regarding the magnitude of the risk faced by employees should, to the extent possible, re'.y on quantitative expressions of that risk, utilizing the best available data. The Court stated that the significant risk determination required by the OSH Act is "not a mathematical straitjacket." and "OSHA is not required to support its finding that a significant risk exists with anything approaching scientiFic certainty. '"A reviewing court (is| to give OSHA some leeway where its Findings must be made on the frontiers of scientific knowledge (and that) *" the Agency is free to use conservative assumptions in interpreting the data C35793 A 287 Federal Register / Vol. 48, No. 215 / Friday. November 4. 1083 / Rules and Regulations 51089 with respect to carcinogens, risking error on the side of ovcrprolection rather than underprotection" (488 US at 655. 6561- In the case of asbestos, the data available are of unusual breadth and high quality. However, because risk assessment itself involves many uncertainties. OSHA made certain assumptions in its analysis and evaluation of these data. In assessing the risk for asbestos-exposed workers, OSHA has attempted to use realistic assumptions, although the court stated that the Agency was free to use "conservative assumptions" in interpreting data. OSHA, in many cases, has indicated where different assumptions may produce different results. In addition OSHA cautions that because the risk figures finally derived are the products of a process which, as the Supreme Court acknowledged, is "on the frontiers of science," they should be viewed as approximations of the degree of risk faced by asbestos-exposed workers and not as precise fixed predictions of the number of workers who will actually develop disease. OSHA has evaluated the kinds of dangers presented by asbestos exposure, the quantification of those dangers under present asbestos exposure conditions, the quality of the data on which risk estimates are based, a comparison of asbestos risks to other occupational risks, and relevant policy and legal considerations in concluding that workers are exposed to a grave danger from asbestos. 1. Nature of the Diseases. As stated above, the nature of the disease associated with exposure to a toxic substance is one of the most important elements OSHA evaluates in determining whether a grave danger exists. This factor was discussed in Florida Peach Growers Association. Inc. v United States Department of Labor, supra. The court, in overruling OSHA's organophosphate pesticide ETS, observed: We reject any suggestion that deaths must occur before health and safety standards may be adopted. Nevertheless, the danger of incurable, permanent, orfatal consequences to workers, as opposed to easily curable and fleeting effects on their health, becomes important in the consideration of the necessity for emergency measures to meet a grate danger. 469 F 2nd at 132 (emphasis added) OSHA is aware of no instances in which exposure to a toxic substance has more clearly demonstrated detrimental health effects on humans than has asbestos exposure. The diseases caused by asbestos exposures are in large part life-threatening or disabling. Among these diseases are lung cancer, cancer of the mesothelial lining of the pleura and peritoneum, and asbestosis. In addition, workers exposed to asbestos are at increased risk of gastrointestinal cancer, as shown by epidemiologic studies. Although colo-rectal cancer may be curable if detected in an early stage, other gastrointestinal cancers are usually fatal. OSHA also believes that asbestos might induce cancers at other sites, which are also often fatal. Of these, lung cancer constitutes the greatest health risk for American asbestos workers and has accounted for more than half of excess mortality in some occupational cohorts. About 90% of lung cancer patients die within 5 years of diagnosis. Mesothelioma is an incurable cancer which is usually fatal within a year after diagnosis. It is epidemiologically linked to asbestos exposure, and occurs very rarely, if at all. in persons never exposed to asbestos. Asbestosis, a type of pulmonary fibrosis, is usually non* reversible, its advanced stages are disabling, and can be fatal. OSHA concludes that all these diseases are very serious, and that the excess mortality from such severe diseases must be considered an important factor for making a grave danger determination. 2. Degree of Risk of Developing Dangerous Disease. OSHA based its calculations of extent of risk faced by workers under current exposure conditions primarily on the results of a quantitative analysis which derived numerical estimates of cancer risk at various cumulative exposures corresponding to levels at which workers are exposed (Ex. 84-392). Although 2 (fee is the current PEL for asbestos exposure, actual exposure conditions vaty widely, mostly by industry segment. As explained later in this document and as set forth in Table I. average ambient exposure levels in various industries include high exposure levels such as 20 f/cc in drywall removal, renovation and demolition; 5 f/cc in shipbuilding and repair; mid range exposure levels such as 2 f/cc in secondary fabricating of cement sheet, packing and gaskets and paper products and rebuilding and refacing brakes; 1.5 f/cc for dry processing of textiles; and lower exposure levels such as 0.5 f/cc and 0 2 f/cc in the manufacture of floor tile. Because OSHA is required to consider the actual danger faced by workers in assessing whether exposure to a substance presents a "grave danger", OSHA looked at the risk of developing disease not only at the 2 f/cc permissible level but at all exposure levels which workers currently face. Most of the results of these calculation-, for cancer are presented in Table 11 in the risk assessment section of this document. The table sets forth predicted excess lifetime cancer risks for exposures of one year. 20 years and 45 years. Risks for exposures of 6 months are closely approximated by one-half the risks for exposures of one year. Although averag? exposures in demolition and renomion are estimated at 20 f/cc. the table presents risks only for selected exposure levels up to 10 f/cc. These calculations show that the risks of asbestos-related disease are alarmingly high at current occupational exposure levels. For example, an estimated total cancer risk of 265 excess deaths per 1000 workers exists for workers exposed for a 45-year lifetime at 10 f/cc, a level which currently exists on some construction sites. At 5 f/cc. the exposure levels which are considered average in shipbuilding and repair, the risk of developing asbestos-related cancer for a 45-year exposure period is 149 excess deaths per 1000 workers. At the current permissible level of 2 f/cc which also represents actual exposure levels in such industries as secondary fabricating of cement sheet, packing gaskets and paper products and rebuilding and refacing brakes, risk is estimated as 64 excess cancer deaths per 1000 workers for a 45-year exposure period. These risks remain very high when the period of exposure for which calculations are done is shortened to 20 years, which OSHA believes is another appropriate point for examination. The period of 20 years is the approximate midpoint between 1 year and 45 years of exposure; also many workers receive 20 years of exposure. Counterpart risk calculations using a 20-year exposure period are: for workers exposed to 10 if cc. 140 excess cancer deaths per 1000 workers: for exposures to 5 f/cc. 105 excess cancer deaths per 1000 workers and for exposures to 2 f/cc. 44 excess cancer deaths per 1000 workers. OSHA also estimated risks of developing cancer for a one year period of exposure at various levels to which employees are exposed. The counterpart risks for exposures to 10 f/cc for one year are; 15 excess cancer deaths per 1000 workers: to 5 f/cc. 7 excess cancer deaths per 1000 workers and to 2 f/cc. 3 excess cancer deaths per 1000 workers. Even at current workplace exposure levels which are less than the current PEL, extraordinarily high risks of disease exist At 0.5 f/cc. 17 excess cancer deaths per 1000 workers are C3&793 128& / ; 51090 Federal Register / Vol. 48. No. 215 / Friday. November 4. 1983 / Rules and Regulations predicted for a 45-year lifetime exposure, and 11 excess cancer deaths per 1000 workers for a 20-year exposure period. OSHA notes that the above calculations are for cancer risk only. In addition, asbestos-exposed workers face a high risk of developing asbestosis. a . disabling and often fatal disease. Predictions concerning the estimated magnitude of the asbestosis risk, have been performed by OSHA and are discussed in the risk assessment section of this document. Accordingly, OSHA estimates that at 2 f/cc. 50 workers per 1000 exposed to asbestos for 45 years will develop disabling asbestosis. Al 0.5 f/cc for 45 years, it is estimated that 12 workers per 1000 will develop disabling -asbestosis. Asbestosis risks can also be estimated for exposures for durations shorter than 45 years. For example, the risk ofdisabling asbestosis from exposure to 1.0 f/cc for 22.5 years is 12 cases per 1000 workers. OSHA's estimates of the magnitude of the asbestosis risk are based on sound data from good epidemiological studies. OSHA believes, however, that the confidence which can be placed in predictions of asbestosis risk is not as great as for the predictions of cancer risk. This is because the cancer risk estimates are based on a larger and more varied data base and are derived from dose-extrapolation models that are better established. Because OS1IA has determined that the risks for cancer alone indicate a grave danger, the additional risks of developing asbestosis are not necessary to justify this ETS. However. OSHA has considered that the additional and independent risk of developing asbestosis increases the danger faced by exposed workers and underscores the gravity of the health threats to employees posed by asbestos. 3.Quality of Data on Which Risk Estimates are Based. The underlying data upon which the quantitative risk assessments for asbestos are based are high quality epidemiologic studies, conducted in occupational environments. OSHA emphasizes that , the data bases for asbestos are of unusual quality and size. Unlike most potential occupational carcinogens, asbestos has been studied often and thoroughly for evaluation of its effects on occupational populations. In deriving these quantitative estimates for cancer risk. OSHA utilized eleven studies for the calculation of the lung cancer risk, four of which were also used to calculate the mesothelioma risk. Investigations involved "cohort" studies where the frequencies of various types of cancers in workers exposed to asbestos were compared to those in "control" groups not exposed to asbestos or to those of general populations such as U.S. males. Studies of such design are able to provide direct estimates of excess risk. The studies used by OSHA in deriving dose-response relationships for its risk assessment covere'd a variety of work situations and industrial processes. This variety improves the predictive value of the risk assessment because it lessens or eliminates the possibility that the results were unique to any one occupational situation or were in fact aberrational. The occupational settings studied were: workers exposed at a chrysotile textile plant from 1930-4975 (fiement et al. Exs. 84-038 and 84-037); Canadian workers at an asbestos cement facility (Finkelstein Ex. 84-240); Italian chrysotile miners and millers who worked during 1930-1965 (Rubino et al. Ex. 64-86); workers in an asbestos cement pipe plant (Weill et al. Ex. 84206); workers in an asbestos production plant and asbestos cement nioe factory (Henderson and Enterline Ex. 84-48); British workers manufacturing asbestos textile products (Peto Ex. 84-169); asbestos miners and millers in Quebec. Canada (Liddell et al. Ex. 84-59); and in the Thetford Mines. Canada (Nicholson el al. Ex. 84-72); and workers manufacturing asbestos friction materials fBerrv and Newhouse Ex. 84Slj. "Well-conducted epidemiologic studies that show a positive association between an agent and a disease are accepted as the most convincing evidence about human risk" (Risk Assessment in the Federal Government: Managing the Process. National Research Council. 1983. p. 21, Ex. 84322). No extrapolation from animal data to human data is necessary in order to show carcinogenicity of asbestos. For most substances. OS1 LA must infer human health effects, such as carcinogenicity, from animal data. The results of this risk assessment. performed by OSHA agree well with other recent risk assessments performed by other governmental and outside scientists (see Acheson and Gardner) (Ex. 84-216 and 84-243): EPA (Ex. 84180); Kang and Chu (Ex. 84-001); Selikoff et al. (84-002); and CHAP (Ex. 84-256). 4. Comparative Analysis. Insight into the magnitude of the risk associated . with asbestos exposure can be gained by reviewing other occupational risks. OSHA believes it is instructive to compare asbestos risks with other workplace hazards agreed on as presenting an unusually high degree of hazard, where the data are considered both available and reliable. The risk of excess mortality estimated as a result of exposure to asbestos al the conditions in the workplace today appears to be substantially higher than other risks experienced by workers from occupational injury*hazards. The National Safety Council (NSC) has reported the annual death rates in 1981 from work accidents in a variety of industries (Ex. 84-339). Using the NSC data OSHA has reviewed the annual mortality from work accidents per 1000 workers in several industries in light of the excess cancer mortality from a single year of exposure to asbestos per 1000 workers. For example, in the high risk occupations of agriculture and mining-quarrying, the annual mortality rates from work accidents were 0.54 and 0.55 per 1000 workers respeclively in 1981 (Ex. 84-339). In contrast, the death rate from work accidents for all industries combined was 0.12 per 1000 workers in 1981. OSHA has estimated that the lifetime risk for one year of exposure to 2 f/cc of asbestos is about 3 excess cancer deaths per 1000 exposed workers during the remainder of the workers' lifetimes (Ex. 4-349). Thus, asbestos workers' risk of excess cancer mortality from a single year of exposure to 2 f/cc is rnnghly s times higher than the risk of acdrlpnt.il occupational fatalities from one vpar nf employment in agriculture and miningouarrving. As shown in Table 1. OSHA estimates that many workers are exposed to asbestos in the vicinity of 2 f/cc. Tn addition. OSHA calculated the average excess cancer risk to workers exposed at conditions that exist in the workplace today (for those above 0.5 f/cc ar.d using the scenario described in Table 3). OSHA estimates that 10 excess career deaths will occur per 1000 workers for 1 year exposure: thus the average risk to workers (exposed above 0.5 f/cc) in the workplace today is approximately 20 times the annual fatal accident rates in agriculture and mining-quarrying. These comparisons are striking. They show that the estimated risk of dying of cancer from asbestos exposure at levels existing at the workplace today far exceeds the accidental death rate in the riskiest of industries. Although the estimated mortality rates for cancer due to asbestos exposure are not completely comparable to the total actual accidental fatalities, the review is clearly useful in shotving that the magnitude of the asbestos risk is grave. One example of predicted cancer risk as a result of occupational exposure is the following cancer risk estimated from 7 I C35793 12S9 y Federal Register / Vol. 48. Mo. Z15 / Friday, November 4. 1983 / Rules and Regulations 51091 occupational exposure to ionizing radiation. The estimated excess cancer fatality rate from 47 years of exposure to the maximum permissible occupational exposure to ionizing radiation (5 rents) is 17 to 29 per 1000 workers (Committee on the Biological Effects of tonizing Radiation (BEIR) 111 predictions, see 48 FR 1902). However, most radiation standards (unlike OSHA standards) require that exposure limits bo reduced to the lowest level reasonably achievable below the exposure limit (the ALARA principle). Approximately 95 percent of radiation workers have exposures less than one-tenth the maximum permitted limit. The excess cancer deaths,at one-tenth the permitted level are 1.7 to 2.9 per 1000 workers exposed 47 years. Asbestos exposures of 45 years to 2 f/cc are predicted by OSHA to result in 64 excess cancer deaths per 1000 workers beginning work at age 25 (Ex. 84-392). OSHA's calculation for the average excess cancer risk to worker exposed at conditions that exist in the workplace today (for those above 0.5 f/cc) for a 45year exposure, is 196 excess cancer deaths per 1000 workers. This figure was calculated by taking the number of cancer deaths estimated from exposure to existing conditions for 45 years for those workers exposed to greater than 0.5 f/cc of asbestos and dividing by the number of workers exposed to asbestos greater than 0.5 f/cc (multiplied by 1000). Therefore, the excess cancer risk at 2 f/cc for asbestos workers.is estimated as more than twice as high as the maximum permitted radiation cancer risk and about 25 times higher than the estimated cancer risk of 95 percent of the workers exposed to radiation. At existing conditions, asbestos workers' excess cancer risks are estimated to be 85 times higher than the cancer risk faced by 95 percent of the workers exposed to radiation. The risk of asbestosis further increases the significance of the risk from asbestos exposure. At 0.5 f/cc. OSHA estimates that 17 excess cancer deaths will occur in 1000 workers exposed 45 years. This risk is approximately 7 times higher than the cancer risk faced by 95 percent of the workers exposed to radiation. OSHA finds that these comparative risks strongly support OSHA's finding that workers exposed to air concentrations above 0.5 f/cc are far above the point of significant risk and are at grave danger of dying from cancer. 5. Conclusion. OSHA's finding of "grave danger" is based on evidentiary and policy considerations. OSHA's determination that the magnitude of the estimated risk to exposed workers is alarmingly high constitutes the major component of the -grave danger" finding. The overall extraordinary degree of risk, the extent that very high risk is found in many asbestos using industries, and the unusually high quality of the data utilized to make these assessments present a very strong evidentiary basis for a "grave danger" finding. Just as importantly, the unique gravity of asbestos-caused diseases, in particular cancer, such as mesothelioma which is linked almost exclusively to asbestos exposure, strongly supports OSHA's finding of grave danger. Also OSHA's comparison of the risk of asbestos-related disease to other industrial risks underscores the extraordinarily high risk estimated for asbestos exposure. OSHA has also noted the concerns of workers about current workplace conditions and the numerous petitions for an ETS from unions representing many exposed workers. Finally OSHA has relied on its experience devaluating and regulating workplace hazards in recognizing the extraordinary degree, of risk currently faced by asbestos workers and in determining that suqh risk constitutes a grave danger to those workers. B. Need for an ETS OSHA has determined that this ETS is necessary to protect employees from grave danger, the second prong of the Act's test of OSHA's exercise of its ETS authority (Section 6(c) of the Act). As ` explained in detail, the effect of this ETS is to save many lives which would otherwise be lost to asbestos-related disease if current working conditions were not changed. OSHA believes that employees can be adequately protected against this grave danger only by issuing an ETS. This is because no other Agency action and no other foreseeable event would result in sufficiently reduced asbestos exposures that would alleviate the grave danger. Further, the provisions of the ETS are tailored to effect the necessary exposure reductions expeditiously. 1. Lives Saved by Issuing an ETS. OSHA has estimated the number of deaths avoided as a result of an ETS which would reduce the PEL to 0.5 f/cc (see Tables 2 ar.d 3). For cancer only, based on continuing exposures under currently existing conditions for 6 months, the potential number of lives saved is estimated as approximately 210. Based on continuing exposures at currently existing conditions for 1 year, the potential number of lives saved is estimated at approximately 426. Also. OSHA has estimated that the promulgation of an ETS setting a 0.5 f/cc PEL may avoid 5725 cancer deaths assuming 20 years exposure to asbestos of the current workforce at current conditions and 7815 cancer dea'hs assuming 45 years exposure. OSHA is aware, of course, that Section 6(c) of the Act limits the effective time of an ETS to 6 months, and OSf fA concludes that a grave danger exists and an ETS is necessary even if OSHA focuses exclusively on this six month period. However, the Agency believes it is appropriate to calculate benefits deriving from an ETS using lifetime risks from 20 and 43 years of exposure to the PEL of 0.5 f/cc established by the ETS. Although the ETS expires within 6 months. Section 6(c) requires that rulemaking on a permanent standard also be completed within 6 months, so that there will be no gap in protection for exposed employees. In OSHA's experience and judgment, complying with this statutory directive and completing rulemaking for a permanent standard within 6 months of an ETS has and can be done. OSHA also believes, based on its experience, that it is very likely that the PEL established after 6(b) rulemaking will be no higher than 0.5 f/cc. the ETS limit. Therefore. OSHA believes that the ETS will result in a reduced lifetime worker exposures of 0.5 f/cc or lower for 20 or 45 years, and that the benefits derived from these exposure reductions for these time periods are appropriately attributed to OSHA's promulgation of this emergency standard. a. Employee Exposures. To derive these estimates of numbers of lives saved. OSHA depended on its knowledge of the following factors: (1) The employee exposure levels from the ambient asbestos air concentrations in the workplace: (2) the number of workers exposed at the various asbestos levels: (3) the duration of the exposure: and (4) the probability of the disease (or the risk) associated with the cumulative exposure. Employee exposure levels are conv entionally measured In terms of the number of asbestos fibers that are 5 microns or more in length in one cubic centimeter of air, f/cc. In these terms, an ambient concentration may seem to be a small amount of asbestos. However, in physical terms, 2.0 f/cc equals 2.000 OoO fibers per cubic meter (f/m'1). Humans inhale about one cubic meter of air per hour, depending on degree of physical activity. Thus, at this concentration, a worker would inhale roughly 16.000.000 fibers. 5 microns or mure in length, over an eight hour workday. C35793 Federal Register / Vol. 48. No. 215 / Friday. November 4. 1983 / Rules and Regulalions t 51099 respirators (with a protection factor exceeding 10) must be worn drops from 20 f/cc (10 limes the former PEL of 2 f/ cc) to 5 f/cc (10 times the new PEL of 0.5 f/cc). Therefore OSHA believes that more workers will wear more protective respirators under the ETS than under the current permanent standard, that their actual exposure levels will be reduced to below 0.5 f/cc and consequently that their risks will be reduced even more than the calculations indicate. OSHA finds also that requiring a training program to be instituted as quickly as possible is one of the most effective methods of maximizing the beneficial impact of the exposure reduction and of all the protective provisions of the current standard. Thus, the content of this ETS has been chosen as the most effective short-term strategy to reduce asbestos risks which will be accepted and implemented. 0. Conclusion. OSHA finds that workers exposed to asbestos in the workplace at existing exposure conditions need this emergency temporary standard to protect them from the grave danger presented by these conditions. OSHA finds that by compelling a reduction in exposure to 0.5 f/cc for those employees presently exposed over that level, many lives will be saved. Training imposed by the ETS will enhance the risk reductions, although quantification of that additional reduction cannot be calculated. 0.5 f/cc is the lowest feasible level achievable through this emergency action, where short-term implementation of the controls is required. Only by issuing an ETS compelling reductions in exposure levels below the current permissible limit of 2 f/cc can OSHA bring about adequate reductions in risks. The administrative action of stepping up enforcement of the current standard is an inadequate response to OSHA's finding that current conditions present a grave danger. OSHA does not believe that any significant reduction will occur within an acceptable time period without this emergency standard action. OSHA has observed a gradual reduction in asbestos use. but, in the Agency's experience, significant and rapid exposure reductions usually occur in response to standards. The provisions of the ETS will significantly reduce the risk and reduce it quickly. Therefore OSHA has determined (hat the ETS is necessary to reduce the grave danger. IV. Occupational Health Data A. Introduction 1. Asbestos-related Diseases. Asbestos exposure can cause a number of disabling and fatal diseases. Among these diseases are lung cancer, cancer of the mesothelial lining of the pleura and peritoneum, and asbestosis. It is also likely that asbestos increases the risk of gastrointestinal cancers. Of all the diseases caused by asbestos, death from lung cancer constitutes the greatest health risk for American asbestos workers. Lung cancer has been responsible for over half of the excess mortality from asbestos exposure in some occupational cohorts. The relationship between lung cancer and asbestos exposure has been established by numerous epidemiologic studies of diverse groups. Asbestosinduced lung cancer usually has a latency period in excess nf 20 years and may be diagnosed at an earlier age than for non-exposed persons (Craighead el al.. 1982: Ex. 84-033]. Few cases of lung cancer are curable despite advances in medical and surgical oncology. Only 9% of lung cancer patients survive five or more years after diagnosis (American Cancer Society, 1983; Ex. 84-160). Asbestos exposure acts synergistically with cigarette smoke to multiply the risk of developing lung cancer. Mesothelioma also has been conclusively shown to be associated with asbestos by many studies. In some asbestos-exposed occupational groups. 10%-18% of deaths have been attributable to malignant mesotheliomas. Malignant mesotheliomas of the pleura and peritoneum are extremely rare in persons not exposed to asbestos. Generally, a latency period of at least 25 to 30 years is required in order to observe mesotheliomas in an occupational cohort. Some victims of mesothelioma have had a latency period exceeding 40 years since their initial exposure to asbestos (Craighead et al., 1982: Ex. 84-033). This form of cancer is rarely curable and is usually fata! within a year after diagnosis. There is no evidence for a relationship between cigarette smoking and mesothelioma risk. Asbestos exposure can cause pleural and/or other pulmonary disease. Pleural plaques are one of the markers of exposure and may develop within 10 to 20 years after the initial exposure. Plaques are opaque patches visible on chest X-rays that consist of dense strands of collagen (connective tissue protein) lined by mesothelial cells. All commercial types of asbestos induce plaques. Plaques can occur even when fibrosis is absent and do not seem to reflect the severity of pulmonary parenchymal disease. Pleural calcification is also commonly found in persons who have been exposed to asbestos (Craighead et al.. 1982; Ex. 84033). Asbestosis is pulmonary fibrosis caused by the accumulation of asbestos fibers in the lungs. Adverse effects of asbestosis range from shortness of breath upon exertion to cyanosis, effusions of serous fluid, respiratory failure, cardiac decompensation, and death. Often, asbestosis is a progressive disease, even in the absence of continued exposure. Symptoms of disease are shortness of breath, cough, fatigue, and vague feelings of sickness. When the fibrosis worsens, shortness of breath occurs even at rest. One clinical feature of early asbestosis as well as other lung diseases is end-inspiratory crackles (rales). Diagnosis of asbestosis is based upon the presence of characteristic radiologic changes, symptoms, rates, other clinical features of fibrosing lung disease and a history of exposure to asbestos. Cigarette-smoking asbestos workers may have an increased risk of asbestosis relative to non-smoking asbestos workers. (Craighead et al., 1982: Ex. 84-033). Some epidemiologic studies have observed increases in esophageal, stomach, colo-rectal, kidney, laryngeal, pharyngeal, and buccal cavity cancers. While the magnitude of increased cancer risk for these sites is not as great as for lung cancer and mesothelioma, the increased risk is nevertheless of considerable importance because of the high background rates of some of these tumors in the general population. A 50% increase in a common cancer such as colo-rectal cancer results in many more deaths than a 50% increase in a rare cancer. Colo-rectal cancer, if detected and treated in an early localized stage, has a five year survival rate of about 70% (American Cancer Society 1983; Ex 84-160). Surgical and medical treatment is less successful for the other sites listed above. Adverse effects from exposure to asbestos have been observed in workers involved in asbestos cement pipes and shingles manufacturing (Enterline et al.. 1973a. 1973b; Weill et al.. 1979; Finkelstein. 1982. 1983) (Exhibits 84-122. 84-123. 84-206. 84-044. 84-240). asbestos mining and milling (Wagner et al. 1960: Liddell et al- 1977; McDonald et al.. 1980; Hobbs et aL 1980: Nicholson et al.. 1979: Rubino et al.. 1979) (Exhibits 2-21. 84-059. 84-065. 84-132. 84-072. 84-086). asbestos textile manufacturing (Doll. 1955; Peto el al.. 1980; Berry el al.. 1979; \ C35T93 1291 51100 Federal Register / Vol. 48, No. 215 / Friday, November 4, 1983 / Rules and Regulations Dement et al,, 1983) (Exhibits 84-040, 84169, 84-020. 84-037). insulation work ISeliknff et al- 19791 (Exhibit 84-090). shipbuilding (Selikoff et al., 1979; Blot et al.. 1980: Tagnon et al.. 1980) (Exhibits 84-091, 84-109, 84-182), and in a variety of asbestos products manufacturing. industries (Jones et al.. 1980; Henderson and Enterline, 1979: McDonald and McDonald, 1978; Seidman et al., 1979; Robinson et al.. 1979; Acheson et al., 1981) (Exhibits 84-138. 84-048. 84-154. 84-087. 84-082. 84-103). It should be noted that 2_fibersjjer_ cuhic_centimeter, which is the current OSHA standard, is equivalent to 2 million fibers' per cubic meter ojjji. Because humansbrealheln about a cubic meter of air every hour, depending on physical exertion, the current OSHA PEL for asbestos allows workers to inhale 2 million asbestos fibers per hour during an 8-hour work day. For the sake of brevity, subsequent discussion in this preamble will express exposure In terms of fibers per cubic centimeter (f/cc) rather than fibers per cubic meter. Note.--The current OSHA standard includes asbestos fibers 5 micrometers or more in length, thereby excluding shorter fibers. Since up to 98% of airborne asbestos fibers are shorter than 5 micrometers, workers may inhate up to 100 million asbestos fibers per hour during an 8-hour work day. Since OSHA's publication of a notice of proposed rulemaking in 1975. additional studies have confirmed that asbestos exposure causes a high risk of cancer. In addition, much more complete data on the nature of dose-response relationships for asbestos-induced diseases are now available. These studies generally indicate that the PEL set by OSHA in 1972 is inadequate to protect asbestos workers from either lung disease or cancer. The following agencies and organizations have reviewed the health data for asbestos: International Agency for Research on Cancer (IARC) (1977, Ex. 84-321). Organization for Economic Cooperation and Development (OECD) (1979. Ex. 84-337). NIOSH (1970.1980. Exhibits 84-338 and 84-320). Advisory Committee of the Health and Safety Commission of the United Kingdom (1979, Ex. 84-216), the Chronic Hazard Advisory Panel on Asbestos (CHAP) (1983. Ex. 84-256). and the U.S. Environmental Protection Agency (1982. Ex. 84-180). All of these groups have concluded that there is a causal relationship between asbestos exposure and the development of cancer and nonmalignant respiratory disease. NIOSH recommended reduction of the PEL for asbestos to 0.1 fibers per cubic centimeter (0.1 f/cc) in 1976. In 1980. a Joint N'lOSH/OSHA Asbestos Work Group stated that there was no level of exposure to asbestos below which clinical effects did not occur and recommended a PEL of 0.1 fibers per cubic centimeter (0.1 f/cc), based on the limitations of current technologies of measuring air concentrations of asbestos. The 1979 report cf the Advisory Committee of the Health and Safety Commission of the United Kingdom, hereafter referred to in this Bection as the U.K. Committee, led to the reduction of the British standard for asbestos to l f/cc for chrysotile. 0.5 f/cc for amosite. and 0.2 f/cc for crocidolite. Currently, it appears that the United Kingdom may lower the PEL for chrysotile to 0.5. 2. Evaluation of Risk. OSHA's first step in analysis of risk of disease from . exposure to a potentially hazardous agent is a qualitative evaluation of scientific data. This evaluation involves reviewing human and experimental studies to consider such factors as overall study design, methods of data collection, biologic plausibility of findings, consistency of findings from different studies, temporal correctness of the association, and other factors as well as general scientific judgment Subsequently, after a specific agent has been judged to be hazardous, the quantitative exposure-response relationships between the agent and disease can be investigated. The available data on air concentrations of the substance or biological indices of exposure, such as fiber contents within lungs, can be reviewed for cohorts of workers demonstrated to have an increased risk of disease. If workers with an observed excess risk of disease have received cumulative exposures permitted by the current OSHA permissible exposure limit, then a potential significant health risk from exposure to the PEL has been established. If the workers with observed excess risk received cumulative exposures above those permitted by the current PEL then risk from the current PEL may be estimated from risk observed at higher levels by using dose-response extrapolation models. The section. Epidemiologic Evidence on Risk from Exposure at the Current PEL, will discuss the extent to which excess risk has been observed from low exposures to asbestos. Section V., Quantitative Risk Analysis, will discuss the prediction of excess risk from low asbestos exposures using doseextrapolation models based on studies observing excess risk in humans. OSHA considers that both risks observed by studies and risks predicted by dose- extrapolation models are valid indicators of the existence of significant health risks. Exposure data frequently are not available for workers exposed before 1970. Where historical exposure data are available, the data often have such limitations as having been collected and analyzed using industrial hygiene techniques no longer in use or having been collected in only some areas of the worksite or having been collected on only a few occasions. Therefore, of necessity, estimates of dose-response based on epidemiologic studies will have a fairly broad range of uncertainty. OSHA must examine the best available data on exposure-response to arrive at a determination of significance of risk, despite inherent and inevitable uncertainties in the data. The current 8-hour time-weighted average PEL for asbestos of 2 fibers per cubic centimeter (2 f/cc] envisages that workers will not receive a cumulative exposure exceeding 100 f/cc-years ( = 2 f/cc X 50 years of occupational exposure]. For asbestos, OSHA believes that a number of studies suggest that increased risk of lung cancer, asbestosis. and mesothelioma have occurred from cumulative exposures estimated as close to or below 100 f/cc-years. Note.--OSHA typically uses 45 years as the period of a full working lifetime for purposes of quantifying risk from exposure to toxic agents. For asbestos, many scientists have used 50 years to represent a full working lifetime. Thus, both 45 years of exposure and 50 years of exposure are used in this document for the purpose of analyzing dose-response relationships for asbestos. In these studies, the cumulative exposures resulted from exposure levels greater than the current OSHA PEL of 2 f/cc for an 8-hour day. For example, workers who accumulated ICO f/ccyears could have been exposed to an average level of 5 f/cc for a period of 20 years. Section B(3), below, discusses the epidemiologic evidence fOrrisk from low exposures in more detail. OSHA believes that a significant health risk has been observed for cumulative exposures that could be accumulated by workers exposed to no more than the present PEL of 2 fibers per cubic centimeter (2 f/cc). Estimates of cumulative exposure are approximations of total dose received by a worker during the period of employment involving exposure to asbestos. Cumulative exposures generally are estimated by multiplying the varying intensities of exposure, such as the 8-hour time-weighted averages, by the number of year's exposed. Most theories of the mechanism of C35793 12S2 | HI? ^/v ' sUt- lr>- ^ u' ' (Ua*** PROPOSED RULES be separately coded In the interna- pleted In 1966. Recent measurements, peared that the recognized, continuing onal classification of diseases. It may using modern fiber-counting methods, Important health hazard of asbestosis count for one death In several thou were correlated with earlier dust assess could be controlled on the basis of cur sand In the absence of an environmental ments using other techniques. This al rent observations. or occupational asbestos exposure. In lowed estimates of 4-15 fibere/ml tobe It was known at the time that asbes some groups of asbestos workers, It may made of worker's exposures since 1933 tosis was not the only disease that could account for one death In ten. In the factory (Berry, 1973). These re- occur as the result of asbestos exposure. Once established, the other asbestos ported data carried considerable weight Reports were available that workers so associated cancers differ little from those because information on both exposures exposed were also at increased risk of occurring in the general population, al and their effects were available. More developing several types of cancer, and though there may be variations in the over. all of the 290 Individuals examined these reports had demonstrated that location of the primary site. Appropriate and x-rayed by the company medical de such risks were present during the use treatment and prognosis follow for the partment had been employed for at least of asbestos in the United States, In fac particular tumor. There is very limited 10 years; 112 had been employed for 20 tory production of asbestos products, and long term survival from lung cancer years or moTe. There had thus been some In their subsequent use (Mancuso and therapy: and only somewhat better from opportunity to observe the incidence of Coulter. 1963; Selikoff, Churg and Ham treated cancer of the colon or rectum. asbestosis associated with longer expo mond, 1964; Enterline and Kendrick, Asbestosis and asbestos cancer-- sure to asbestos, a factor of some im 1965). However, these data had not, vet whether it be lung cancer, pleural meso portance since abnormal findings are been ffllly evaluated in terms of the thelioma. peritoneal mesothelioma, can often not seen until a significant period extent ol risk in large parts of the asbes- cer of the stomach, colon, rectum--usu of time has elapsed from first exposure. tds Industry in the United States and ally do not become clinically evident until The Committee of the British Occupa there were few data which would allow more than 20 years have passed from tional Hygiene Society, in evaluating the Judgment concerning Intensity and ex- onset of exposure. This time-frame is Information given to It on the recorded tent of exposure to asbestos in relation now widely recognized. While some such exposures in this plant and the Infre to tne subsequent risk oi asbestos-asso cancers may appear during the second quency of disease among the workers ex ciated cancer. The British Occupational decade following onset of occupational posed to dust at these levels, came to the Hygiene Society's Committee had recog exposure, peak Incidence is often not conclusion that, by lowering the per nized this problem in Great Britain as noted until 'the 30-years-from-onset mitted level still further, to a flWs/mi well, but developed its standard based on point, or later. This is true both with as a time-weighted average, employees Information related to the risk of devel regular, long-term asbestos work, and coulcTbe permitted to work Si such en oping asbestosis, noting in its report following short-term, brief or Intermit vironments lor a full working iife~time (1968) that it was "not possible, at this tent exposures. While variations in the (St) yearsT without substantial risk~of time, to specify an air concentration time of occurrence may depend upon in developing asbestosis. It was calculated which is known Will bd iree of l'C&hc5rl tensity and duration of exposure,' with that workers exposed to 100 fiber- risk. In setting its stanaara. usHa noped heavier exposure often being associated years/ml, that is, to 2 flbers/ml for 50 that reduction of exposure levels de with shorter latency periods, variations years, 4 fibers/ml for 25 years, or 10 signed to prevent asbestosis would also among individual cases make It Impos flbers/ml for 10 years) wpuld have a 1% serve to control the hazard of asbestosis- sible to predict the latency period for risk of developing early signs of as associated cancer. In this, it placed con the risk of any particular worker. bestosis. siderable reliance on an additional facet B. PRIOR HISTORY The British Committee published in of the British experience. Concurrently, 1968 its report "Hygiene Standards for a published report from the same fac Jn 1971 in response to a petition of Chrysotile Asbestos" for the prevention tory by its medical director and recog the Industrial Union r>pnR'~tT"aT>t, aft -- of Asbestosis" in 1968. At the time, there nized statisticians (Knox. Holmes. Doll wpi-e-few riata-fii comparable nature in and Hill, 1968) had indicated that no a standard regulating occupational ex the__United States. While extensive significant increase in cancer mortality posure to asbestos. At that time, it had clinical and epidemiological studies of had been found among workers first em been established that asbestosis was the health effects of asbestos exposure on ployed in this 1)13111 subsequent to 1953. a major cause of disability and death American workers had been made, com when the improved conditions mandated among workers regularly exposed to as paratively few dust counts had been by the 1931 Factory Regulations came bestos dust in occupational circum recorded during the years in which the into effect. stances in the United States, where the exposure of these workers had occurred. Since the promulgation of the U.S. principal opportunity for such exposure > Moreover, tfri dust counts that had been permanent asbestos standard, considera occurred in the manufacture of asbestos \ taken had utilized ter.hnlniies other than ble new information has been forthcom products, and their use (Mancuso and the new membrane filter counting meth ing on the toxic effects of asbestos. This Coulter. 1963: Selikoff, Churg and Ham ods. for these reasons. NIOSH. in its has been in two areas: in the widen mond. 1964; Selikoff, 1965; Enterline and evaluation of considerations relating to a ing spectrum of cancers associated with Kendrick. 1967: Selikoff, Hammond and standard for occupational exposure to asbestos exposure, and in various mani Churg, 1968'. The hazard of lung scar asbestos (NIOSH, Criteria Document, festations of asbestos disease in indi ring resulting from the. inhalation of 1971) stated that the recommendation of viduals exposed to relatively low con asbestos F'nshast/isis") had heen a con the British Occupational Hygiene Soci centrations of dust. This exten tinuing problem from the time of Its first ety was "given great weight in the devel sion of the initial data within recent identification (Departmental Commit opment of this standard." years now requires refocusing of OSHA's tee. 1907; Cooke. 1924: Merewether and The asbestos standard set by OSHA concerns from a primary function of pre Price. 1931 and m-eessen. et al. 1938). in 1972 was thus based on a number of vention of asbestosis with the expecta Data suggest that the Incidence of well-characterized observations. Lung tion of concomitant reduction hi the in asbestosis would be markedly diminished scarring ("asbestosis") had been de cidence of asbestos-associated cancer, to by reduction of occupational exposure to scribed as an important complication of a new orientation, that of primary con Identified levels. In factories and during - occupational exposure to asbestos during cern with the prevention of asbestos- end product use. The British Occupa tional Hygiene Society reported In 1968 (Subcommitteeon Asbestos, British Oc cupational Hygiene Society, 1968) that It had been given data by a single large asbestos tevtiie mill which indicated that there was comparatively little clinical and/or roentgenological evidence of nsr the original descriptions of the problem in Great Britain. It hud been found equally important in U.S. studies in the 1930's, and more recent Investigations in the 1960's had demonstrated that it had continued as a serious problem. However, from the British Occupational Hygiene Society's evaluation of factory data re cancer. There is an additional logic in this reorientation. Reduction of as bestos exposure to levels sufficient to pre vent asbestosis is known, at least In some Instances, to be insufficient to prevent asbestos-cancer. On the other hand, a reduction of asbestos exposure to an ex tent sufficient to prevent asbestos-asso bestosls at this factory in a survey com lating the incidence of disease it ap ciated cancer will also prevent asbestosis. FEDERAL REGISTER, VOL. 40, NO. 197--THURSDAY, OCTOBER 9, 1975 7 C35793 1293 PROPOSED RULES -ITG.'il These new observations should not di minish OSHA's prior focus on the pre vention of asbestosIs, since significant pulmonary and/or Pleural scarring-haye not been an important fcatirro nf-lrmr. level, short-term. Intermittent PYnnsnm. In many groups of asbestos workers, approximately 20% of all deaths are caused by lung neoplasms. This has been true both among asbestos product fac tory workers (Selikoff, Hammond and Churg, 1972; and Nicholson, 1975) and Rather, it should emphasize the Lncom- among users of these products (Selikoff, plete perspectives of the current standard Hammond and Seldman, 1973). The ex derived from considerations concerned act percentage varies with circumstances with prevention of asbestos-related lung of exposure, age of the workers, duration scarring rather than those needed for of the workers' exposure and, perhaps the prevention of asbestos-associated most of all, according to the duration cancer, particularly mesothelioma. from the onset of their asbestos work C. THE NEW XVUtSCE <l) Asbestosis. Subsequent to the hear ings on the current standard, uncertainty has arisen as to whether the existing British asbestos standard and the man dated 2 fiber/ml U.S. standard provides effective protection even against asbesto sis. The data from Great Britain ob tained in 1966 Indicated that little clini cal disease, including x-ray evidence of asbestosis. had occurred among workers first employed In that factory at some time after 1933, when Important im provements in work practices had been achieved. In 1972, results of evaluation of new x-rays that had been taken in 1970, of the work force then employed In the same factory, were reported as showing that many now had abnormal findings either in the lung or in the coverings of the lung pleurae (Lewinsohn, 1972). There was thus a difference prevalence of abnormal r-ra.v findings among workers x-rared in 1966 as re ported to the British Occupational Hy giene Society, and evaluation nf other x-rays of workers In the same factory four years later! Additionally, clinical data are becom ing available concerning asbestos lung scarring in individuals exposed at levels much lower than those of occupational circumstances. Among 210 family con tacts of former asbestos lactnrv work ers, 38% have been reported to have x- ray changes characteristic ot asbestos exposure (Anderson, Selikoff, Lilis and Daum, 1975). (2' Cancer. In Decemhpr 1972. Impor tant new informatlon_nn the of asbestos cancefS was presented at the conterence on "the B[nlngleal Effects nf Asbestos, sponsored by the International Agfency tor Kesearcn on Cancer of the WOriiTHflaith Organization. Atthis con ference, and subsequently, data on large groups of asbestos workers became avail able 1 Selikofft HammoncLancLSeidman, 1973: Enterline. 1972) . As expected, the risk nf hrnnrhnoenie. rarclnnma-anrt mesothelioma persisted among factory employees and Insulators. Moreover, these later studies confirmed the excess gastrointestinal cancer TEat had*T)een suggested earlier, and extended the spec trum of asbestos related cancers. (a) Lung cancer. The most Important cancer afflicting asbestos workers is can cer of the lung, although mesothelioma history. In addition, the last several years have seen the discovery of another crit ical variable affecting the incidence of lung cancer among asbestos workers. In 1968, Selikoff, Hammond aud Churg re ported that lung cancer was not signifi cantly .increased in Incidence amongasbestos workers with no history nf rig, arette smoking, although when such his tory was present, the incidence of lung cancer increased markedly over what would be expected among other cigarette smokers, in the absence of asbestos ex posure. Thus, these scientists calculated that an asbestos worker who smnked cig arettes had 92 times the risk of dying of lung cancer, as compared with like in dividuals without cigarette smoking or asbestos work. This finding has been confirmed by larger studies (Hammond and Selikoff, 1973) where, again, it was found that non-smoking asbestos workers had lew lung cancers while those who smoked had much more lung cancer than would have been expected hid they not been asbestos workers. Calculations suggest that cigarette-smoking asbestos workers have approximately eight times the risk of developing lung cancer Compared to other smokers. "(b) Pleural and peritoneal mesothe lioma. In 1960, Wagner, Sleggs and Marchand demonstrated an Important asso ciation between asbestos exposure and pleural mesothelioma. This cancer, which appears to be unrelated to smok ing, had previously been considered to be a very rare tumor. Numerous reports have confirmed the finding of Wagner and his colleagues that mesothelioma can be commonly associated with asbes tos exposure. A subsequent report by Enticknap and Smither, 1904. concerning workers in a British asbestos factory demonstrated that the same tumor could be commonly found In the abdomen (peritoneal mesothelioma), as well as in the chest. The exact risk of death of these In variably fatal neoplasms has not been as well defined as has lung cancer, al though recording of cases from hospitals near one large asbestos factory has Indi cated that it must be very common lndeed (Borow, Conston, Llvornese and .Schalet, 1973). Information available from the experience of asbestos Insula tion workers suggests that approximately five to seven percent of deaths may be due to this neoplasm (Hammond, Seli has attracted considerable attention be koff and Churg, 1965; Selikoff. Ham cause of the high frequency among as mond and Seldman 1973). More recently, bestos workers and infrequent occurrence it has been suggested that this estimate in the population as a whole. ' is too low, on the basis of the experience of workers in a British asbestos factory where calculations predicted that be tween 10 and 11 percent of deaths would be due to mesothelioma (Newhouse and Berry. 1975). (c) Gastro-tntestinal cancer Gastro intestinal cancers (cancer of the stom ach, colon and rectum) are also In creased in Incidence among asbestos workers, but the increase is less pro nounced than that of lung cancer or mesothelioma. A number of studies now indicate that the Increase is on the order of two or three times the number of ex pected tumors (Selikoff, Hammond and Seidman, 1973: Elmes, 1968). Although this increased risk is relatively limited, especially when compared with lung cancer and mesothelioma. It is neverthe less of considerable Importance since i. two- or three-fold increase to such com mon tumors becomes an Important cause or qeatn for the workers involved . It has been suggested that other tu mors are also increased in Incidence among asbestos workers, particularly cancers of the larynx (Stell and McGill. 1972; Newhouse. 1973) and neoplasms of the oropharynx (Selikoff. Hammond and Churg, 1970), and of the esophagus (Se likoff, Hammond, and Seidman, 1973 . However, data concerning these neo plasms are less extensive than for lung cancer, mesothelioma and gastro-lntestinal cancer and further experiences 3re awaited. In any case, they are not very common tumors in general and any in crease does not weigh heavily on the overall cancer risk of asbestos workers. Considering all neoplasms, among some groups of asbestos workers, em ployed either In asbestos factory work or in the use of asbestos products, as much as 40 to 45 percent of all deatlrs have been due to one or another type of can cer. an approximately three-fold or four fold increase. Of significant Importance, new date, have recently been made available con cerning the cancer risk of workers at the textile mill reviewed for the British standard, including those workers first employed after 1933 (Howard, Kinlen Lewinsohn, Peto and Doll, 1975). It was found that there was excess mortahtv from lung cancer among those workers who entered scheduled areas after : January 1933. There was "clear evidence of some excess of lung cancer and res piratory deaths among those flist ex posed between 1933 and 1950." Equal!;, important was the finding that "there still appears to be an excess of deatlis duo to lung cancer after 15 or more years' exposure" even among those flist ex posed in 1951 and subsequently. Indeed, it is known that mesothelioma deaths have occurred among the specific group of 290 workers whose experience prior to 1966 had led to the development of the current standard, as detailed above (Brody, J. E.. 1974). There are further data indicating the necessity for revaluation of the asbestos standard, albeit less directly derived from asbestos worker exposure. This in formation is derived from occurrence of asbestos cancer among Individuals cx- FEOERAl REGISTER, VOL 40, NO. 197--THURSDAY, OCTOBER 9, 197 5 C35793 1294 PROPOSED RULES to low levels of asbestos, as In en_>ai circumstances, or to brief or jttent exposures to higher levels. _ analysis of the history of asbestos _^poUure among Individuals In a large i aeries of cases of mesothelioma In Great Britain and South Africa have provided evidence that brief or Intermittent ex posure to asbestos may, after the pas sage of decades, result In mesothelioma (Oreenberg and Lloyd Davies, 1974; Webster, 1973). In such circumstances, it appears that the lifetime exposure was leas than the 100 flber-years/ml envis aged by the current standard. The same discrepancy between present projected exposures and the risk of asbestos cancer exists when considering cases of meso thelioma resulting from household con tact to asbestos among members of families of asbestos workers (Llllington, 1974)- or among residents living in the vicinity of asbestos plants. Of considerable Industrial importance, hasbeen the recent description of ash^itnc disease among shipbuilding and ship repair workers, few of whom actu ally work with asbestos, but many of Xf whom were, in the past, inadvertently " exposed to the asbestos dust resulting from" the use or asbestos proflucU by a relatively few of their worn mates, in 1968, Harries of the ttoyai navy reported cases of mesothelioma among shipyard workers at the Royal Navy dockyard In Devonport. In trades which did not di rectly Involve worker exposure to as bestos, but In which there had been oc casional opportunity for exposure merely by virtue of working In the same areas. This original finding has been widely confirmed and numerous cases of meso thelioma have since been reported in former shipyard workers (Whitwell and Rawcllffe, 1970; McEwen et al, 1970; Stumphius, 1968; Greenberg and Lloyd Davies, 1974). Studies of populations of current shipyard workers have shown much radiological evidence of asbestos abnormalities among workers in trades only Indirectly exposed to asbestos In the yards (Sheers and Templeton, 1969; Fletcher, 1972). GUlam et al (1975). studying the mor tality and reviewing the chest x-rays of 439 underground metal miners exposed to an asbestlform mineral, found three times the risk of malignant respiratory disease than expected. The fiber concen trations averaged 0.24 flbers/ml. Further, evidence has indicated that asbestos also acts as a lung carcinogen at levels much below those which will produce asbestosis. Two surveys of ship yard workers who had x-ray evidence of pleural plaques, but generally not of pul monary fibrosis, showed a 2.5-fold excess , risk of death from lung cancer and high risk of mesothelioma. (Fletcher. 1972; Edge. 1975). In a study of the mortality experience of a large D.S. asbestos prod ucts manufacturing facility, It was found' that workers In low-dust, ureas with a minimum risk of death from asbestosis. had the same high risk of death from various cancers as workers In dustier areas (Nicholson, 1975). m. Certain Considerations Concerning Carcinogenicity In the case of asbestos, we are dealing with a substance that poses a range of health risks to the working population. These include the threat of cancer, as well as asbestosis. In considering the controversial Issue of carcinogenicity, OSHA Is relying upon not only the new data reviewed above, but the leading scientific principles and opinions be lieved to reflect the research conclusions of International cancer experts, which were developed since or not known to OSHA at the time that the original standard was promulgated. A. THE LATENCY Or CARCINOGENIC EFFECTS In humans, the liftency period for chemical carcinogens may well extend between 20 to 40 or more years. Analo gous periods exist for test animals. This means that the diesase may undergo a long development before a tumor is ac tually detected. At that point, It has reached a stage where removal of the worker from the workplace may be of no avail and where treatment may be extremely difficult. If not futile. Prudent policy would therefore seem to Indicate that every reasonable measure should be taken to eliminate human exposure to chemical compounds as soon as their carcinogenic nature Is identified. B. VARIABILITY IN INDIVIDUAL SUSCEPTI BILITY IN RELATION TO THE jCONCEPT OF A THRESHOLD Cancer development may be Influ enced, by such factors as the differing susceptibility of various body organs. In animal studies It has been found that Individual variability in response to car cinogens is great depending upon factors such as age, sex, hormonal status, diet, and genetic factors. Thus. In the work ing population. Certain groups, such as those already biologically compromised, may be more susceptible than other groups. c. a "threshold" limit Because of the variability of Individ ual response to carcinogens and other factors, the concept of a "no effect" or "threshold level" may have little real significance on the basis of existing knowledge. While some level, below which exposure to a carcinogen does not cause cancer, may conceivably exist for any one individual, other Individuals in the working population may have cancer Induced by doses so low as to be effectively zero. This is not to say that researchers will never find a threshold level for a carcinogenic sub stance, but It does mean that the thresh old concept for carcinogens Is, at pres ent, more a matter of responsible regu latory policy than a precise, scientific determination. These theoretical concepts have a bearing on the asbestos Issue, particu larly as to the question of the existence, or nonexistence, of a threshold level of carcinogenic effect. A "no effect" level theoretically may exist, but it has not been demonstrated. In previous rulemaking proceedings, OSHA has considered these issues and determined that In the absence of evi dence to establish a safe level on the basis of present knowledge, employee ex posure must be reduced as low as feasible. (See the preambles to the carcinogen standards 29 CFR 1910.1003-10016 (39 FR 3758): the vinyl chloride standard 29 CFR 1910.1018 <39 FR 35892) ; the coke oven emissions proposal (40 FR 32268), and the beryllium proposal.) OSHA welcomes all views and com ments on these subjects. IV. Pertinent Lecal Authority The primary purpose of the Act is to assure, so far as passible, safe and healthful working conditions for every working man and woman. One means prescribed by Congress to achieve this goal Is the authority vested In the Secre tary of Labor to set mandatory safety and health standards pursuant to Sec tion 6(b) of the Act, 29 U.S.C. 655<b). The standards setting process permits the participation of Interested parties in the consideration of medical data, in dustrial processes and other factors rele vant to the Identification of hazards and the selection of appropriate control measures. Occupational safety and health standards provide notice of the permitted exposure levels and provide a basis for ensuring the existence of safe and healthful workplaces. Section 6(b) (5) of the Act, 29 U.S.C. 655(b) (5), pro vides that: The Secretary, in promulgating standards dealing with toxic materials or harmful physical agents under this subsection, shall set the standard which most adequately as sures, to the exteat'feaslble, on the basis of the best available evidence, that no employee will suiter material impairment of health or functional capacity even If such employee has regular exposure to the hazard dealt with by such standard for the period of his work ing life. Development of standards under this subsection shall be based upon research, demonstrations, experiments and such other Information as may be appropriate. In addi tion to the attainment of the highest degree of health and safety protection tor the em ployee, other considerations shall be tbe latest available scientific data in the field, the feasibility of the standards, and expe rience gained under this and other health and safetv laws. Sections 2(b) (5) and (6), 20, 21. 22. and 24 of the Act reflect Congress recog nition that conclusive medical or scienti fic evidence. Including causative factors, epidemiological studies or dose-response data, may not exist for many toxic ma terials or harmful physical agents. Nevertheless, standards cannot be post poned because definitive medical or scientific evidence is not currently available. Indeed, while final standards are to be based on the best available evi dence. the legislative history makes It clear that "it Is not Intended that the Secretary be paralyzed by debate sur rounding diverse medical opinion." H.Rpt. No. 91-1291. 91st Cong., 2d Ses sion, p. 18 (1970). This Congressional Judgment has been supported by the FEOERAl REGISTER, VOl. 40, NO. 147--THURSDAY, OCTOBER 9, .1975 A C35793 1295 1195 Current Report Asbestos OSHA PROPOSAL HAS ALTERNATIVE LIMITS, CONSIDERS 'FLEXIBILITY' IN COMPLIANCE The Occupational Safety and Health Administration April 10 issued a proposed rule for occupational exposure to asbestos containing two alternative permissible exposure limits of 0 2 fihers per cubic centimeter of air or 0.5 f/ccas an eight-hour time-weighted average. This supplemental proposal, together with the agency's Nov. 4 notice of emergency temporary rulemaking on asbes tos, constitute proposed revisions to the permanent standard regulating occupational exposure to asbestos in general industry, the maritime industry, and the construction indus try, according to OSHA (49 PR 14116). A 1976 notice of proposed rulemaking, which had excluded the construction industry, was withdrawn and replaced with this proposal. OSHA noted that the emerpenrv standard -- which was struck down by a U.S. appeals court in March on the grounds that the agency failed tn show any necessity for emergency action (11 OSHC 1817) -- had set a 0.5 fiber limit. At that lime, available evidence indicated that this level was the lowest attainable. However, the agency's current regulatory analysis indicates that for most industries, a lower limit of 0.2 f/cc is feasible, the notice stated. In addition, OSHA is "considering allowing flexibility" in the methods chosen to achieve compliance with a PEL below two f/cc. The agency is considering allowing respira tors to be used in place of engineering controls or work practices to reduce worker exposure to the lower PELs of 0.5, 0.2, or 0.1 f/cc, rather than considering respirators as a supplemental method to be used only after engineering controls and work practices have achieved maximum feasi ble results. Engineering controls and work practices, howev er, remain the mandated methods of achieving air concen trations of two f/cc. An informal rulemaking hearing is scheduled to be held at 10 a.m. on June 19 at the Department of Labor, the notice stated. In addition to believing that employees exposed to asbes tos at the previous two f/cc limit face a significant risk to their health, OSHA stated that it "also believes that a significant risk remains at exposures to the proposed alter native PELs." However, recent available evidence indicates that either 0.2 f/cc or 0.5 f/cc is an appropriate limit to propose in light of feasibility limitations, particularly re garding asbestos measurement accuracy at low levels, ac cording to the notice. At the conclusion of the rulemaking, OSHA plans to adopt a PEL which reflects evidence in the record concerning health risk and technical and economic feasibility, and which may be higher or lower than the limits proposed. OSHA Seeks Comment The agency requested submission of written comments, data, and other evidence from interested persons on several major issues raised in the proceeding including: What exposure limits would provide protection of em ployees against known and suspected workplace hazards of asbestos and what feasibility limitations exist in setting any given limit. Whether the permissible ceiling limit should be reduced and, if so, what the revised limit should be. To what extent, if any, should the standard be modified for workplaces which are of a non-fixed nature or otherwise engage a highly transient workforce. Whether the changes in the definitions of "asbestos" and "asbestos fiber" would clarify the standard's intended scope, and properly relate to known or suspected workplace hazards. Whether OSHA should modify the existing medical sur veillance provisions to change the frequency of exams or their content. Whether an expanded medical removal program should be provided where, as a result of the medical surveillance program, it is determined that an employee is at an in creased risk of material impairment of health from further exposure to asbestos. Whether and under what circumstances it is feasible to reliably measure asbestos concentrations at levels of 0.1, 0.2, and 0.5 f/cc. Whether the evidence associating asbestos exposure with lung cancer, mesothelioma, and gastrointestinal cancer is adequate and whether OSHA's assessment of risk is scientifically valid. Whether regulatory distinctions should be made for dif ferent asbestos fiber types. Whether OSHA should require the use of engineering controls and work practices to reach the new permissible exposure limits. Whether the provisions of the proposed standard are cost-effective. Construction and Asbestos In addition, OSHA is considering three different ap proaches to the format of regulations governing asbestos exposures in the construction industry. The approaches are: to continue to apply the same standards as amended, to all industries, perhaps adjusting certain requirements for the construction industry; to limit the scope of an asbestos standard for the construction industry to setting permissible exposure limits, with additional protection provided by re course to relevant OSHA standards of general applicability; or to develop a separate standard for asbestos exposure in the asbestos industry. The agency is requesting comments concerning a number of major issues, including: Whether the TWA permissible exposure limit adopted for general industry should apply to the construction industry. Whether the present requirements for initial determina tions for each place of employment are feasible for nonfixed workplaces that may exist for short periods of time. Whether any change from the present rule should be allowed concerning sampling frequency and patterns. Whether the nature of the exposure patterns in demoli tion necessitates special provisions. 4-12-S4 t Occupational Safety & Health Reporter 0095-323?/W/$0+.50 C35793 1296 1196 OCCUPATIONAL SAFETY & HEALTH REPORTER Whether more explicit fit testing requirements should be mandated for construction employment and the content of such programs. Whether the present requirements for personal protec tive equipment are adequate to protect asbestos workers in the construction industry. What facilities and hygiene practices are appropriate to protect construction industry employees exposed to asbestos. What, if any, recordkeeping requirements should be mandated for the construction industry. Upon completion of this rulemaking, OSHA said it will consider whether changes in the present standard for the construction industry are warranted, and if so, what those changes should be and how they should be made. OSHA may, on the basis of information submitted as part of this rulemaking, adopt specific changes in the current standard for the purpose of addressing unique construction industry con cerns. The agency also may issue a separate standard, in whole or in part, dealing with occupational exposures to asbestos in construction work, the notice remarked. In any case, OSHA stated that it intends to codify the asbestos construction standard at the place designated for construction standards, 29 CFR Part 1926. Written data, views, and arguments should be submitted by May 25 to the Docket Officer, Docket No. H-033C, Occupational Safety and Health Administration, Depart ment of Labor, 200 Constitution Ave., N.W., Washington, D.C. 20210. All material submitted will be available for public inspection at the above address. Persons desiring to participate at the hearing must file in quadruplicate a notice of intention to appear by May 10 addressed to Tom Hall, OSHA Division of Consumer Affairs, Docket No. H-033C, Room N-3635, DOL, Third St. and Constitution Ave., N.W., Washington, D.C. 20210; telephone: (202) 523-6024. The notice of proposed rulemaking appears in the Full Text section of this issue. Lead D.C. APPEALS COURT WILL VACATE STAY; OSHA TO DETERMINE DATE FOR COMPLIANCE PLANS A draft order that would vacate a current stay of two lead standard provisions for primary and secondary smelters and battery manufacturers was submitted by the Occupational Safety and Health Administration to the U.S. Court of Ap peals for the District of Columbia Circuit. OSHA was directed by the appeals court April 6 to write the draft order, at a hearing before Circuit Judges Wilkey, Mikva and Bork in the case of United Steelworkers of America v. Auchter (Nos. 83-1022 and 83-1126). The court indicated it will use the OSHA draft document as the basis for an official court order vacating the stay effective June 1. The court also noted that the order would be issued "without prejudice" to rulemaking on related topics. OSHA spokeswoman Susan Fleming told BNA April 10 that the court order is expected soon. In ordering OSHA to submit a draft order, the appeals court gave attorneys for the union and for the industry groups involved an opportunity to review and comment on the draft. This review was to have been completed by 5 p.m. April 10. The smelting and battery manufacturing industries were granted the administrative stay in December 1982. The stay relieved employers in those industries from having to com ply with lead standard provisions at 29 CFR 1910.1025(eX3XiiXB) and (E), which require employers to tell OSHA how they specifically intend to achieve compliance with the lead standard, and what schedule they will follow in implementing the compliance program (Reference File, 31:8422). In granting the stay in response to industry petitions, OSHA noted that it was at that time conducting a general reevaluation of the lead standard, which had been issued by the Carter Administration in 1978. The stay, OSHA said, was intended to spare employers in the smelting and battery manufacturing industries any unnecessary costs that they might incur in complying with requirements that were "under agency reconsideration" (Current Report, Dec. 9, 1982, p. 563). The United Steelworkers of America filed suit against the agency, contending that Assistant Secretary Thorne Auchter did not have authority to issue the interim and final stays. The union also argued that OSHA's reason for granting the stay was no longer valid, since the agency had not issued a revised lead standard. Notice Superseded Prior to the hearing, OSHA had written a notice for publication in the Federal Register proposing to vacate the administrative stay, and asking for public comment on the proposal within 30 days. In that notice, OSHA acknowledged that it had not issued a proposal to modify the compliance plan requirements of the lead standard. It also noted a recent initiative by the Steelworkers, ASARCO, and the agency to develop tripartite agreements on lead controls at ASARCO plants (Current Report, Feb. 2, p. 947). Such efforts to determine feasible engineering con trols "will be aided by the development of compliance plans," the notice said. The notice was filed with the Federal Register the morning of April 6, before the hearing, but then withdrawn after the court issued its order for a draft document from OSHA lifting the stay. OSHA spokeswoman Fleming noted that the agency now must determine the date on which employers in the smelting and battery manufacturing industries must have their com pliance plans ready. OSHA is preparing a notice for the Federal Register that will propose an effective date for the compliance plan requirements, and request public comment. Fleming said that the notice probably will appear "within the next week or so," after the appeals court formally issues its order vacating the stay. OSHA Deputy Administrator Patrick Tyson told BNA in February that a proposed lead standard revision currently under review by the Office of Management and Budget would give a five-year extension to secondary lead smelters for installing engineering controls (Current Report, Feb. 23, p. 1014). Tyson, who currently is serving as acting adminis trator for the agency, said April 10 that "if we do make any changes to the lead standard involving compliance dead lines, we will make appropriate revisions to the provisions covering compliance plans." Electrical Safety HEARING PARTICIPANTS ASK OSHA TO RELY ON NEC FOR ELECTRICAL SAFETY STANDARDS Numerous participants in the Occupational Safety and Health Administration's public hearing on the agency's pro- t 4-12-84 I Copyright 1984 by The Bureau of National Affairs. Inc. 0O9S-3Z37/84/SO+.S0 C35793 1297 Johns-Manville Corporation 1978 Annual Report m .. relying upon basic business philosophies and concentrating on superior products and services, controlling expenses and expanding in areas of high return..." H&S Industrial Hygiene C35793 A298 Asbestos Issue n> o> 3_"3 1978 the media continued :$ sensationalized coverage of the ev.s-its and government hearings r.c ;mg occupational health re asbestos-related diseases. : s a credit to the officials of the z.r 'Dnmental Protection Agency and r~ Occupational Safety and Health -z~ mstration that they have -a 'tained a rational and scholarly acc'oach to the asbestos situation in :~e ;ace of so many exaggerated : a ~s by the media and plaintiff a.1, .ars. jghout history whenever there as seen adversity or tragedy, men sought a scapegoat. And, even :;a,. it appears that our legal system $ ~:re concerned with finding a fault v a /ery undesired happening than * oroviding fair and reasonable " oensation for the consequences s-ch happenings. : a "ow known that excessive "a ation of asbestos fiber can, over a ca'iod of time, cause or contribute occupational disease. Asbestos, "a a:ed disease does exist; thus, it is i ca-^aps understandable that people : : ^;d cast about for an "asbestos tcaoegoat." What is inexcusable is fa manner in which many lawyers, '"a media, and even some in t'a "public interest" arena have ht to exploit the tragedy of stos-related disease through the 'acstition of inaccuracies, half-truths a' c exaggerations. '"a evidence does not support the a egations leveled at J-M, and we 5f want you, our shareholders, to know the facts. Statements on asbestos and health by the media and some officials have been inaccurate, incomplete, exaggerated and sensationalized. All too familiar are the tendencies of the media to capitalize on and sensationalize tragedy and the eagerness of some in the public eye to grab for quick and easy headlines. Nowhere has this been more evident than in the treatment of asbestos and health issues. While some of the untruths presented by the media and others may be from lack of facts, which in itself is inexcusable, far more often they have resulted from a deliberate distortion in the face of facts and out of a very apparent anti-business bias. For example: A reporter from a leading New York daily newspaper stating to a person being interviewed about asbestos that she was "not interested in facts--only a story." A financial daily newspaper failing to ' publish vital medical information on smoking and its direct relationship to lung cancer in asbestos workers. A newspaper in Norfolk, Virginia publishing a headline misrepresenting the ruling of a United States District Court judge. A cabinet official speculating on disease estimates without disclosing the almost total lack of scientific support for the figures. A Congressman issuing press releases and making inflammatory comments based only upon information supplied by attorneys for people suing the asbestos companies. A "journalist" attacking J-M in Environmental Action magazine, producing an article so inaccurate and vicious as to suggest malice. These examples are not fiction, but merely a few of many instances we have witnessed which exhibit the philosophy, "a good story at any cost." All too often reporters and others have dutifully published as fact the adversary conclusions fed them by lawyers suing J-M. One can but conclude that fantasy and sensationalism make better copy than fact, and that fantasy and sensationalism it shall be. Television producers carefully editing The asbestos-related diseases answers of J-M officials to conform to of today are a result of past high an apparently preconceived story line. exposures which were thought to be safe at the time by the United States A reporter from a Washington, D.C. Public Health Service. daily refusing to explore fully the particular dangers of cigarette Unfortunately, asbestos-related smoking in conjunction with asbestos diseases have a long latency period; exposure because he was only that is. a long period of time between interested in a cover-up story. first exposure and onset of any disease. Accordingly, we know that C35793 1299 the asbestos-related disease being seen today is the result of exposure of 20, 30 and 40 years ago when medical knowledge concerning asbestos was only a fraction of what it is today. In years past people were exposed to airborne asbestos particles in excess of what is now considered a safe exposure level. In 1938, limits for exposure to asbestos were recommended by the U.S. Public Health Service and adopted shortly thereafter by the American Conference of Governmental Industrial Hygienists, and these limits were accepted by industry as safe working conditions for employees. Further, these levels were accepted without criticism by government health officials and the medical and scientific communities for over 30 years. Knowledge subsequently gained has shown the earlier research to be incomplete. This is the simple fact, not sensational ...but true. Individuals exposed to asbestoscontaining insulation materials are particular victims of the incomplete knowledge of earlier years. Much of the present asbestos litigation involves individuals who were overexposed to dust from industrial thermal insulation materials which contained small amounts of asbestos (usually less than 15 percent). Incidentally, many of these persons worked in environments controlled by the government and used products which were delivered tg government specifications. Scientists and physicians studied these workers and repeatedly concluded that their occupational exposures to asbestos were consistently below the "safe level" recommended by the United States Public Health Service. In fact, in 1946, eminent scientists employed by the United States Navy studied several shipyards and concluded that insulation work was "not a dangerous occupation"--a finding which went uncriticized and unchallenged in American medical literature for almost 20 years. It was not until 1964 that the particular risk to this category of worker was clearly identified by Dr. Irving J. Selikoff of Mt. Sinai Hospital in New York City. We are asked why earlier knowledge generated from studies of mine, mill and factory situations where workers had been exposed to 100 percent asbestos fiber did not lead to earlier knowledge of a possible hazard to those exposed to industrial insulation products. The completely different work environments and experiences were thought by the medical community to make any extrapolation from one group to another invalid. Dr. Selikoff himself indicated this very clearly and concisely in 1970, stating: "In the asbestos mining and manufacturing industry, the risk of heavy exposure to the occupational dusts had been recognized for some years. And this primary industry has understood the need to install ventilation systems and other dust control devices to reduce the hazard. Experience had indicated that reduction of dust levels and exposures could result in greatly improved health experience among asbestos factory workers. But the extrapolation of that experience to another classification of workers-- specifically tnose who fabriciTe and install insulating materials--was a more sophisticated tack fnr Hini^al medicine and epidemiology." How different things might have been had modern methods of medical research been available to the U.S. Public Health Service in those early years. How different things might have been had it not taken the scientists and physicians decades to discover that the recommended iimiis were not stringent enough. Perhaps it is partly the frustration of "how different things might have been" that causes the shallow thinker to engage in hindsight and raise questions about standards of conduct. Unfortunately, such an exercise contradicts the facts. J-M has acted responsibly to discover the cause of and elimina:e occupational disease among asbestos workers. Media representatives and some elected officials have consistently ignored J-M's intensive efforts to solve asbestos health problems and, in fact, have untruthfully portrayed those efforts. Whether such untruths have been deliberate, we leave to reasonable men to judge. But, it is clear that J-M's actions have been appropriate and proper. Some examples of action taken by J-M: C35793 1300 Initiation in 1930 of the first American The first to place warning labels on medical studies of possible health asbestos insulation products in 1964 hazards from asbestos. This was in in response to the new evidence that response to information that the dust from such products might create heavy and constant asbestos a hazard to people working with exposures in the textile mills of the products. England might be hazardous. These studies preceded by years any Continued funding of independent independent action by the United medical and scientific research States Public Health Service or any including that of leading experts such medical organization. as Dr. Irving J. Selikoff of Mt. Sinai Hospital in New York City. Organization in the 1930's of industry support for extended research at the Cooperative programs with industry Saranac Laboratories of the Trudeau and with labor organizations to Foundation, a leading pulmonary disseminate information about disease research facility. asbestos and health, and to continue research. Voluntary adoption and adherence to the recommended exposure limits of Adoption of mandatory no-smoking the United States Public Health Service. programs for workers occupationally exposed to asbestos--the first broad-scale, anti-cancer program in Physical examination programs American industry. available for employees continually since the 1930's; leading research The historic concern of efforts in the early detection Johns-Manville for its employees is af disease. exemplified by a 1934 statement stating that it was undertaking Information prepared and investigations to obtain "the best distributed since the 1930's practice possible for the elimination of o inform employees of the work dust and the protection of practices and protections necessary employees." Additionally: o eliminate the hazards recognized it the time. In 1938, "It is the policy of Johns-Manville to make working Respirator programs installed where conditions in its factories and mines xposure might exceed "safe everywhere safe, healthful and xposure levels." pleasant." competitive standpoint to make these installations, we will elect to discontinue a particular operation rather than knowingly endanger the health or life expectancy of a single employee." The numerous allegations made in the public media inferring that Johns-Manville failed to act in a responsible manner in developing and communicating medical and scientific information on the possible health hazards of asbestos in the interest of sales and profits are false and inexcusable. The facts clearly show that nothing could be further from the truth. Johns-Manville's long history of voluntary commitment to the resolution of asbestos-related occupational disease problems is unparalleled in industry, labor or government. The media and government have ignored the connection between cigarette smoking and lung cancer, the most serious and insidious of diseases in asbestos workers. If it were not for cigarette smoking. lung cancer would not be a significant occupational diseasp pmhicm among asbestos workers. This simple, yet crucial, fact has been repeatedly confused by the medical community and continues to be largely ignored by the media and government. Hundreds of engineering projects nd millions of dollars spent for dust ontrol, including the "invention'' of quipment where none existed. / 3 And today, "We equip our plants for the highest degree of personal safety, assuming it is economically and technically possible to do so. When technology is not available, or when it is not feasible economically from a Our knowledge of the relationship of an increased incidence of lu~no cancer among asbestos workers is of rather recent vintage. A few cases of lung cancer among individuals with C35793 1301 asbestosis were reported in the late 1930's and the 1940's, but the researchers were careful to disclaim a causal relationship. In the 1950's an English study strongly suggested an increased incidence of lung cancer. But, an industry-sponsored study of the type recommended by the American Medical Association failed to disclose any such increased incidence in the North American workers studied. This confirmed a 1956 publication by E. Cuyler Hammond, a noted scientist, Vice President of the American Cancer Society and co-author with Dr. Selikoff of many of the leading articles on asbestos-related diseases. In that study Hammond concluded that sufficient evidence did not exist to causally relate lung cancer and asbestos exposure. It was not until the mid 1960's that enough evidence became available to show an increased incidence of lung cancer among individuaJs.who smoked cigarettes and whowere occupationally exposed to asbestos, ToThis day scientists disagree as to whether asbestos is causally related to lung cancer or whether it acts only as a modifier for smokinginduced cancer. However, there is agreement in the medical community on the simple fact set forth earlier: but for cigarette smoking, lung cancer would not have been a significant health factor among people occupationally exposed to asbestos. One can but wonder why the media steadfastly refuses to give any significant or serious attention to the role of cigarette smoking in cancer causation. The few mentions in journals are worded so as to minimize the hazard. Courageously, Rep. Millicent Fenwick of New Jersey recognized the cigarette connection and introduced legislation to provide a system of uniform compensation for asbestos-related disease. This bill called upon the tobacco companies to join the asbestos industry and government in funding such compensation. Mrs. Fenwick's bill died in committee while tobacco subsidy payments were approved as usual. One can but wonder why federal regulatory agencies have made no move to prohibit cigarette smoking among those occupationally exposed to asbestos. J-M has adopted such a non-smoking policy, and amazingly, some of the very same parties who attack J-M for alleged failures to protect employees are now criticizing us for restricting a worker's freedom to smoke. Frankly, it is inconceivable and intellectually dishonest for those who cry cover-up and negligence to ignore the role of cigarette smoking in causing cancer. Charges of cover-up and conspiracy are unfounded. Perception often substitutes for fact and reality: untruths repeated often and loudly become accepted as reality The fact is that there simply is no credible evidence that J-M should have known of particular health hazards associated with asbestos at earlier periods of time than when we did, and there is no evidence that J-M failed to respond appropriately to medical knowledge of possible hazards as the information became available. Faced with this absence of damaging evidence, certain irresponsible members of media, elected officials and lawyers ignore the facts, alleging cover-up and conspiracy, and seek to alter the perception of J-M as a responsive corporation and employer. These allegations are a red herring. A few examples reveal the sham of such allegations: It is claimed that J-M and others conspired in the 1930's to prevent publication of information on asbestos health issues. The fact is that the documents relied on to demonstrate a conspiracy are dated a full 10 months after the publication by the United States Public Health Service of the results of J-M sponsored asbestos medical studies--the first such studies done in this country. If suppression were a goal, publication in the United States Public Health Service reports would seem a poor vehicle to reach that goal. J-M and others are claimed to have manipulated the data published by the United States Public Health Service. Unable to ignore the existence of industry-sponsored medical research, our detractors argue that research conducted by C' Anthony Lanza was tainted by virtue of pre-publication review of the findings. Pre-publication review is nothing sinister, and. in fact, takes place today for virtually all sponsored medical research including that sponsored by the federal government Such allegations are deliberate untruths totally unsupported by the C35793 1302 p Il evidence. No one in the media has had the courage to admit that the review of this 1935 paper resulted in no substantive changes as published by the United States Public Health Service except to accentuate one possible hazard. This can hardly be called a cover-up. There can be but one motive for such a callous disregard of the truth--to distort, mislead, sensationalize and thereby profit from the adversity of others. Another charge is that the industry sought to control and suppress the development and publication of medical information concerning asbestos through its research programs at Saranac Laboratories. Some elementary reasoning reveals this argument for what it is--a myth. If suppression were a motive, why would J-M lead an effort to sponsor and fund research at a leading institution? Additionally, if data were suppressed, then how does one explain the published reports of the Director of the Saranac Laboratories which annually reviewed the ongoing research projects and listed the yearly publications in leading medical journals? How does one explain the attendance of the chief medical officer of the United States Public Health Service at the Saranac Symposia to discuss ongoing research? How does one explain the efforts of J-M and others to speed up, complete and publish research even after the death of the director of the laboratory in 1946? Some allege that J-M's settlement years ago of asbestos disease- related lawsuits meant that we knew of possible hazards to applicators or users of asbestos insulation products long before the medical acknowledgment of such a hazard in the mid 1960's. The fact is that such cases involved neither insulation applicators nor insulation products. They were cases arising out of factory operations in New Jersey, where, due in large part to J-M sponsored research, a possible hazard of continual exposure to raw asbestos fiber in a factory environment had been identified. Neither the product which contained less than 15 percent asbestos nor the work environment were comparable. The workers' claims took the form of lawsuits because in the 1930's asbestosrelated illness was not covered by New Jersey workers' compensation laws. These are facts--unglamorous facts withheld by reporters, public figures and lawyers who must rely on unsupported accusations in an effort to alter perceptions. Perceptions based upon fact are useful in moving the involved parties to a resolution of the problem. But, perceptions based upon untruthful, misleading, inaccurate and unfounded accusations can only delay a much needed consensus on this pressing societal concern. J-M stands ready to join with responsible parties to seek adequate and uniform compensation for asbestos-related illnesses. While the incidence of disease is diminishing and will eventually disappear, the tragic fact remains: asbestos-related disease dees exist, and people have been disabled. There are two options for dealing witn this reality. J-M can continue to litigate claims in the courts, or we can seek an equitable, uniform compensation system. Litigation is based upon a finding of fault, and with respect to asbestos-related disease, there simply is no fault on the pan of J-M. a fact increasingly recognized by juries throughout the nation. Litigation is. of course, favored and fostered by lawyers in search of lucrative fees and by "media personalities' in search of sensational stories. Litigation carries with it persona! hardship for everyone--de'ay. extraordinary expense, and uneven and uncertain results. Fortunately, there is a choice. Forward-thinking members of Congress have concluded that the time for dwelling on fault is past, and the time has arrived to address the issue of compensation for asbestos-related disease. They have proposed a system of speedy, equitable and uniform compensation, and have called upon indusmy and government to share the responsibility of providing the funds necessary to provide compensation. While such a program will be costly perhaps more costly to J-M than continuing to litigate claims. J-M has endorsed the concept, as has the International Association of Heat and Frost Insulators & Asbestos Workers, whose members are perhaps the 27 C35793 1303 B most directly affected. We believe it is the only way in which those injured will be fairly and uniformly compensated without extraordinary delay and expense. J-M and others who support such legislation have been castigated and criticized for such support. Some claim, perhaps from self interest, that such legislation would be a "bail out" of the industry. Far from a "bail out," such a system would, in all probability, entail as great or greater costs to J-M than continuing litigation since the evidence clearly supports the conclusion that J-M acted positively and progressively, consistent with medical and scientific knowledge. A compensation system to replace lawsuits in appropriate situations continues to gain favor among industry, labor, academia, professional task forces within the federal government and members of Congress. It is simply the most effective and efficient way to satisfy a goal of fair compensation for persons suffering from occupational disease. We will continue our support of such programs--it is the right thing to do. There is no evidence of danger in the use of asbestos in schools or other public buildings. Much has been made of the use of sprayed insulation containing asbestos on school ceilings. Again, the facts have been ignored in favor of headlines. Johns-Manville neither made nor sold such materials. Further, the facts are that the use of asbestos spray materials in the construction of schools or other public buildings has not been shown to be hazardous. Nevertheless, a well-designed program to determine the presence of airborne asbestos fibers in such buildings would be prudent. Should excessive levels be discovered, programs to seal or remove the material would be in order. Fibers in most asbestos-containing products are "locked in" and safe. In most of our asbestos-containing products, the fibers are "locked in" by cement, plastic or other binders; such fibers are not easily released during normal handling and application. We are confident that, with proper precautions, asbestos and asbestos-containing products can continue to be used without a health risk. An example of this is asbestos-cement pipe which has been in useful service in the U.S. for decades. After an extensive study, the American Water Works Research Foundation, concluded: "No firm evidence shows that the proper use of asbestos-cement pipe poses a hazard to health by reason of ingestion of asbestos fiber." Summary Johns-Manville has been a leader ;n establishing safety precautions and has acted responsibly over the years consistent with the known facts of the health hazards of asbestos fiber. Ws deeply regret that many people, oufriends, colleagues and employees among them, are currently suffering the effects of having years ago inhaled an excessive amount of asbestos fiber. Cigarette smokers have been especially hard hit. However, there is nothing to be gained by witch hunts to determine fault where none exists. Industry, cigarette manufacturers, governmer: the medical profession, labor, the scientific and academic communities and the media are ail involved. Attention today should not be on assessing blame, but on how those suffering from asbestos-related diseases can be properly and fairly compensated. This is why we, as a company, are encouraging legislation which would establish uniform, equitable and comprehensive means of providing compensation for asbestos-related occupational disease. The events of the past cannot be undone. Johns-Manville has learnec from those events and, today, continues to be a leader in Americaindustry in providing healthful wo^kirg conditions and advanced medical programs for its employees. / C35793 1304 !i51ENVIRONMENTAL FACTS/Asbestos Asbestos and Health INTRODUCTION Asbestos, known since antiquity, has widespread and important applications in our modern industrial society. The increased use of asbestos in the 20th century has led to recognition ot the need to aug ment the efforts to cope with occupational hazards associated with the inhalation ot excessive amounts of asbestos dust. This paper summarizes the es sential uses of asbestos, the known facts about health problems associated with occupational ex posure to asbestos dust, and the research being conducted to identify and reduce these health risks. ASBESTOS-AN ESSENTIAL PRODUCT Asbestos has many essential functions in con struction, in industry and in transportation. Over the years fire-resistant asbestos has saved thousands of lives and much valuable property. For safety, fire prevention and durability, products containing asbestos are used in schools, houses, theaters, office and other public buildings, spacecraft, furnaces, boilers and firefighting equipment. The brakes on automobiles, trucks, buses and trains are depend able because asbestos is a major component of brake linings. WHAT IS ASBESTOS? Asbestos is the name given a family of mineral fibers, including four commercially significant va rieties--chrysotile, crocidolite, amosite and anthophyllite --each ot which differs from the others, physically and chemically. Studies of the relation ship between asbestos and health demonstrate the importance oi these differences. ' These mineral fibers can be divided into two main classes on the basis of their crystalline struc tures: serpentine asbestos and amphibole asbestos. Chrysotile, a flexible white magnesium silicate which can be attacked by acids, and which is the only fiber that carries a positive charge in water, is the lone member of the serpentine class. It has one major difference from the other asbestos minerals; it's generally curly rather than straight and because it is flexible it can be bent into a "U" shape. These characteristics mean that this fiber does not penetrate as deeply into the lung as do the other varieties. The other commercially significant varieties are all amphiboles. Crocidolite is a blue ferrous sodium silicate which is acid resistant and less flexible than chrysotile. Amosite is a brown ferrous magnesium silicate which is brittle and easily pulverized. Anthophyllite is a white mag nesium silicate which is brittle and acid resistant. NO HEALTH RISKS FOR THE GENERAL PUBLIC In this expanding industrial society, many sub stances and materials that could pose health and safety hazards to industrial workers under certain conditions do not, in their finished form.carrv anv risks to the public. This is the situation with asbestos fiber. Research in industry on asbestos exposure has shown that there are occupational health risks associated with on-the-job inhalation of excessive amounts of asbestos dust. Also, in some circum stances in the past, there has been risk to persons living in the immediate vicinity of factories using asbestos, and to members of families of wage earners who worked in occupational exposures and brought home excessive amounts of asbestos dust on their clothes. However, there is no evidence either from experi ence or from scientific study that anyone in the general public has ever contracted any disease from exposure to the wearing or weathering of brake linings, floor tile, roofing, wall or ceiling panels, or similar asbestos-containing items.2 In such prod ucts, the asbestos fibers are bound with cement, plastics or other binding materials, and are not released in significant amounts in normal use. Studies of asbestos tiber concentrations m the public air have shown them to be verv low -- in the order of 1/100 (0.05 asbestos fibers per cubic centi meter of air) of the maximum allowable for occupa tional exposures (5 fibers per cc). The application of automobile and truck brakes does not release significant quantities of asbestos fiber to the atmosphere. Only a small fraction of the asbestos in brakes is dispersed as fiber.-* The remainder is converted by the heat of brake appli cation to a nonfibrous mineral, forsterite. With increasing scientific interest in general air pollution problems, one of many questions being studied is whether city dwellers may be exposed to some asbestos fibers along with other dusts that are known to be in the ambient air. Further attention to this question was aroused by reports of the fmd- C35793 1305 I J ,rn% Wjn..il ENVIRONMENTAL FACTS/Asbestos inn ot a scant number ot so-called "ferruginous (iron-like) bodies" in the autopsied lungs ot some city dwellers. These microscopic bodies are com posed ot protein and iron pigment deposited over specks ot fibrous materials that may remain m the lungs. Urban dwellers are exposed to the dust of more than a hundred different types of fiber, other than asbestos, manv of which can form the core of ferruginous bodies. Similar bodies are also found in the lungs of workers who are exposed occupationally to asbestos fibers. In such cases, they are called "asbestos bodies." This term is sometimes still mistakenly used to designate a ferruginous body, even if the central core material has not been identified as an asbestos fiber. 3 The number of ferruginous (asbestos) bodies found in people occupationally exposed is many umes greater than the number found in the lungs of urban dwellers. It is important to remember that the presence of the few ferruginous bodies found in the various random autopsy studies of city dwellers had no connection with either the cause of death or with any history or symptoms of pul monary disease among the subjects, but only re flected the chance inhalation of some fibrous material in the urban air.2 While research continues on the subject, the facts thus far strongly indicate that the sweeping in ferences that have been made with regard to the possible dangers of public asbestos air pollution are unjustified. KNOWN AND SUSPECTED OCCUPATIONAL RISKS Asbestosis: The industry long ago recognized the risk of a particular lung disease called asbestosis among some workers and took steps to safeguard employees. This non-cancerous disease is brought on only after inhalation of heavy concentrations of asbestos dust generally over a period of many years.5 Asbestosis is one of the lung diseases classified as "pneumoconioses." Among others are silicosis, from crystalline silica dust; byssinosis from cotton dust; talcosis from talc; and anthracosis from coal dust. These are considered industrial health risks against which the various industries have developed protection for the worker. For years, the asbestos industry has taken pro tective measures to reduce exposures to asbestos dust and reduce the risk of developing asbestosis among workers. Practices for handling asbestos fibers have been developed to minimize generation of dust. Complex dust suppression and control systems to present dissemination ot dust are in stalled in many operations Approved respirators are required for workers where dusts are unavoid able. When used properly, these measures have been showrn to afford completely effective protection. Bronchogenic (Lung) Cancer: A number of medi cal studies have reported an association between asbestosis and an increased risk of a certain type of lung cancer (bronchogenic! Although the number of these cases among asbestos industry workers is only a small fraction of the total em ployed, the industry considers the problem a serious one. It has become the subject of considerable scientific research through statistical, clinical and pathological studies of exposed workers; through experimental studies with laboratory animals; and through studies of the physical and chemical na ture of asbestos and associated minerals. Among areas of investigation are the time-dose relation ship; the effect of different varieties of asbestos; the effect of excessive asbestos inhalation com bined with other factors such as cigarette smoking and co-existing trace metals. The belief that asbestos ribers do not bv them selves cause lung cancer was reinrorceu bv a I9b7 study indicating that exposure to asbe-tos among insulating workers greatlv increased the 'isk ot lung cancer but only among cigarette xmewers Among insulation workers who were norwroke-' the Puds showed no more than the expected rate ot lung cancer.6 This conclusion was re-conurmed bv a study completed in 19727 Mesothelioma: Also under studv is a cue disease called mesothelioma, a tumor of the 1 !'est and ab dominal cavity which is different trnm broncho genic lung cancer. Recently, incest:gators ha\e associated an unusually high frequence of cases of mesothelioma with exposure to asbestos m certain geographic locations. This was onginalb reported from certain South African areas where onlv crocidolite asbestos is produced. Howecer m another C35793 1306 !/3iENVIRONMENTAL FACTS/Asbestos trocidolite mining section of South Africa, several hundred miles away, only two mesotheliomas have been found, even though similar technic|ues tor finding these tumors have been used. No meso theliomas have been found among workers en gaged in amosite mining and milling in South Africa. Conversely, cases have been found in em ployees of a New Jersev factory that m the midI940's was making insulation from amosite fiber. These situations have raised the question as to whether factors other than asbestos are involved.8 In the United States, mesothelioma is reported so seldom that there are no accurate figures on its occurrence in this country. In Britain, only two cases are currently reported for every thousand cases of lung cancer from all causes.9 The search for the cause of this unusual disease is hampered by the fact that its diagnosis and recog nition is still considered a problem among medical experts. In several countries mesothelioma registries have been set up to try to collect case histories to learn more about the tumor. It is becoming in creasingly obvious that there are circumstances other than exposure to asbestos fiber that can also cause mesothelioma, to-1' The asbestos industry through research grants is assisting in medical efforts to gain more knowledge about this rare disease. INDUSTRIAL HYGIENE AND PREVENTIVE MEDICINE Today, the asbestos industry has invested millions of dollars in equipment and techniques to prevent the inhalation of asbestos dust by workers in the mining and milling of asbestos and in the manufacture of asbestos-containing products. Johns-Manville continually strives to eliminate dust exposure in the mines and plants which it operates. Processing areas and machinery are equipped with dust suppression and collection devices. Major improvements have been made in fiber shipping methods. For example, Johns-Manville has inaugu rated the use of special railroad cars containing pallet loads of interlocked and glue-locked bags. This procedure permits complete unloading by fork truck, eliminating manual handling of bags. Atmospheric dust levels are monitored regularly. Individual respirators are used where indicated. Employees are given physical examinations to OSHA standards A centralized Department of Environmental Control maintains constant surveil lance over conditions in all J-M plants and mines. Johns-Manville has also conducted a program of consultation with asbestos tabricators. ajjplitators and trade groups such as the Asbestos Textile Insti tute. Asbestos Cement Products Association. na tional Insulation Contractors Association, and Thermal Insulation Manufacturers Association to (provide a thorough understanding of potential risks and to encourage general adherence to sound industrial hygiene practices. Before asbestos-containing fireproofing sprays were legislated out of existence, Johns-Manville voluntarily stopped selling asbestos fiber for this l^urpose. The company deemed this an improper use of asbestos because of the relative impossi bility of effective dust control in the spraying technique used in the United States. The company also participated in a major co operative effort between labor, industry, science and government to conduct a health research pro gram for industrial workers. The Insulation Industry Hygiene Research Program, jointly sponsored by a labor union, the International Association of Heat and Frost Insulators and Asbestos Workers, and by Johns-Manville Corporation, was organized in 1968 at the Mount Sinai School of Medicine in New York City to develop improved methods to minimize exposure of insulation workers --men w'ho apply and remove pipe and equipment insulations in buildings, industrial plants and ships-to dust and fumes encountered in their work. The United States Public Health Service provided consultation and technical assistance. Studies in asbestos-using industries in England and the United States indicate that where effective dust control measures have been taken, the risks of lung diseases have been reduced. 2 ASBESTOS HEALTH RESEARCH Research on the health effects of asbestos has been supported by Johns-Manville since the late I920's. At the Saranac Lake, N.Y., laboratory of the Trudeau Foundation, then one of the leading re search centers for pulmonary disease in the United States, the company sponsored a program of investigations designed to determine safe asbestos dust levels and to eliminate asbestosis among C35793 1307 i jonns Manvme ENVIRONMENTAL FACTS/Asbestos workers in its mines and plants. For more than 20 years the company supported research in this laboratory, basing its continually improved dust control activities on the research findings. Today, scientific research to identity and re duce the health risk from asbestos dust exposure is being conducted in many places throughout the world. The asbestos industry both sponsors such research and cooperates in work being done by government agencies and private medical investigators. Johns-Manville has extended full cooperation to the U.S. Public Health Service in its 7 to 10 year study of workers employed in asbestos pro cessing plants. This epidemiological study will assess the varying environmental factors affecting the health of more than 10,000 asbestos factory workers. In addition, the company provides funds, asbestos materials, equipment and information, as the individual situation may require, for research of such institutes as: The Industrial Health Founda tion of America, The Institute of Occupational & Environmental Health, Mount Sinai School of Medicine, Tulane University, University of Pitts burgh, McGill University, St. Luke's Hospital, Cleveland, Ohio. Johns-Manville also conducts studies on technical aspects of asbestos in its own Research and Development Center in Denver, Colorado.* In cooperation and in conjunction with other agencies, the asbestos industry will continue to seek new information about the biological effects of asbestos fiber and to develop ways of assuring maximum possible protection from occupational hazards for its employees in asbestos mines, mills and plants and among fabricators and applicators of this essential material. EXPLANATORY NOTES 1. Because the major types of asbestos ditfer chemically and physically, they also ditfer in their bio logical effect on humans and in experimental animals. Current knowledge indicates that crocidolite, the type least used in the United States, is most clearly associated with health hazards for people. This is the consensus of a panel of nine medical experts appointed by the British Ministry of Labour - Christy, R. K. and members ot the Refer to History of lohns-Mjnville Health Roseau h.` tCopies available from )ohns-Mjnville) panel. "Problems Arising irom the t se ui Asbestos ller ,\/u/esfCs statKinerv (mice. P'iA Wagner published 'experimental evidence that compared with other asbestos nbei- i rui uioiite pro duces the most sos ere asbestosix in i.i bora tors animals. -- Wagner, J. C.. "Asbcxtosis in Experimental \mrnji>." British journal ot Industrial Medii me lout Ji) i Wagner et al., reported a high numbei ot mesothelioma cases among crocidolite miners and millers in one area of South Africa, but no cases among amo-ite miners and millers - Wagner, J. C.. Sleggs. C and Marc hand, P.. "Diffuse Pleural Mesothelioma and Asbestos Exposure in the North Western Cape Province. ' British Inurna/ of Industrial Medicine, I960. 22 Jut Bv contrast, chrysotile mining areas in other parts of the world have exhibited either no excess or a barelv 'perceptible excess incidence of mesothelioma. Evidence for an important different e m risk in different occupations and with the type of asbestos has increased. The risk is greatest with crocidolite less with amosite and still less with chrysotile. -- Repo.-: or the Advisory Committee on Asbestos Cancers to the Director nt the International Agency tor Research on Cancer or the World Health Organization, meeting at Lvon. France. October 5 and 6, lb72. 2. Only in occupational exposures do asbestos dust levels appear great enough to become possible health hazards. This fact is related to dosage levels as pointed out by Enterline and Kendrick: "Asbestos dust at levels to which general populations are exposed probable is of little importance in the etiologv vausatiom of di sease." -- Enterline. P E and Kendrick M A Asbestos Dust Exposures at Various Levels and Mortalitv," Archives ot Environmental Health. August P>b7. In addition investigators who -enort so-called "asbestos bodies" in human lungs, note that these find ings are not related to cause of death or indeed to anv disease. The comment of Thomson and Craves is representative of those in other studies- But to convert the scanty or very scanty bodies vvinw have demon strated to be present in so mans urban dwellers to the frequency present in a minimal basal u-be'tosis would require an increase bv hundredfolds and to get a more diffuse classical asbestosis with pulmonary disability the multiplying factor might well be m manv millions." Thomson, ]. G. and Craves, W. M.. Asbestos as Urban Air Contaminant." Archives of Patholog\ Mav 196b. "...excess lung carcinoma risk i' not detectable when the occupational exposure has :ven low. These low occupational exposures have almost certainly been much greater than that to the public 'mm general air pollution. There is no evidence or excess nsk of meso thelioma from asbestos air pollution wnich has existed in the neighborhood of chrysotile and amosite mines There is no evidence of risk to the 'general public at present." - Report ot the Advisory Committee on \s- 4 C35793 1308 IZ\ENVIRONMENTAL FACTS/Asbestos t hestos Caneers to the Director ol the International Agency tor Research on Cancer ot the World Health Organization, meeting a! Lvon. France, October 5 iind 6. 1072, 3. So-called "asbestos bodies" in the lung may be produced by other substances. Gross et al.. have ottered experimental proof: "So-called 'asbestos' bodies were produced in the lungs of hamsters injected intratracheally with respirable filamentous particles composed of alumi num silicate... Instead of the term 'asbestos' body, the designation of ferruginous body is suggested." -- Gross, P., Cralley. L. |. and deTreville, R. T. P., "'Asbestos' Bodies: Their Nonspecificity," American Industrial Hygiene Association journal, NovemberDecember 1967. Similar results have been reported by Davis, working at Cambridge University, England. Davis said that hamsters were injected in the trachea and the pleura with dust from aluminum silicate, glass fiber, car borundum and man-made textile fiber. "In both in jection sites all these foreign materials produced bodies which with the light microscope appeared very similar to asbestos bodies. The basic assumption that asbestos like bodies can only be produced from asbestos has proved incorrect." -- Davis, J. M. G., Gross. P. and deTreville. R. T. P., "Asbestos Bodies and Bioeffects -- A Detective Story," Annual Meeting, Industrial Hygiene Foundation, Pittsburgh. October 1967. 4. An uninformed speculation, frequently stated as if it svere a fact, is that the wearing of automobile brakes releases dangerous quantities of asbestos fiber into the air. A study by Lynch of the U.S. Public Health Service, has demonstrated that this statement is erroneous. Lvnch performed laboratory tests of automotive brake linings and found that normal wear releases insignificant amounts of asbestos fiber into the air. He concluded that "the free fibers from brake lining wear appear to be an inconsequential health factor in urban air pol lution." -- Lynch, j. R., "Brake Lining Decomposition Products," journal ot the Air Pollution Control Association. 5. A time factor in asbestosis cases is demonstrated by the study of McVittie showing that clinical asbestosis takes on the average about 17 years to develop.- McVittie, ). C., "Asbestosis in Great Britain." Annals Mew York Academy of Sciences, December il, Pi<->5. 6. Selikoff et al., reported a much higher rate of lung cancer among asbestos workers who smoked cigarettes than among cigarette smokers generally. However, they reported not one case of lung cancer among non smoking asbestos workers. The authors concluded that their evidence "suggests that exposure to asbestos does not lead to an extremely high risk of lung cancer among nonsmokers."--Selikoff, I. )., Hammond. E. C. and Churg,)., "Asbestos Exposure, Smoking and Neoplasia." journal of the American Medical Association, April 8. 1968. A 1969 update of this study reported one case of lung cancer among nonsmokers - Selikoff. I. J.. Hammond, E. C. and Churg. )., "Mortality Experience of Asbestos Insulation Workers 1943-1968," presented at the International Conference on Pneumoconiosis, Johannesburg, South Africa. April-May 1969. 7. Kannerstein and Churg reported in their recent study that lung cancer will not develop in asbestos workers unless they are also cigarette smokers.-- Kannerstein, M. and Churg, ). "Pathology of Carcinoma of the Lung Associated with Asbestos Exposure." Cancer, American Cancer Society, July 1972. 8. The varying prevalence of mesothelioma in the two crocidolite mining areas of South Africa has prompted comment by Wright: "That something other than, or in addition to, asbestos plays a role in meso thelioma formation seems inescapable." Wright, G W , "Asbestos and Health in 1969," American Resiew of Respiratory Disease, October 1969. 9. About 50 cases of mesothelioma are reported annually in Great Britain.-- Gunter, R., Minister of Labour. Official Report to the House of Commons, April 17. 1967. 10. In a study of 76 mesothelioma patients in a London hospital, 25 had no known contact or exposure to asbestos. -- Newhouse and Thompsen. "Mesothelio ma in a London Hospital." 11. In a study of 232 mesothelioma cases in the South African Register, 32 had no asbestos exposure. -National Research Institute for Occupational Diseases of the South African Medical Research Council. Annual Report, 1971. C35793 1309 c c c For further information on this subiect please contact. Environmental Affairs Department. lohns-Manville Greenwood Plaza Denver. CO 80217 EA.3P.375 c c C35793 131 Prated " jSa