Document p2kR63mvr90VnXE9vzGg1wjda

Ofiza CHEMICAL MANUFACTURERS ASSOCIATION OCT 17 1988 iaJjUhwv-OmcWtft---------Vice Prestoent-Techmcal Director Docket Officer Docket No. H-020 Room N-3670 U.S. Department of Labor 200 Constitution Ave, N.V. Washington, D.C. 20210 Dear Sir: The Chemical Manufacturers Association (CMA) is pleased to present post-hearing evidence on OSHA's proposed rule on permissible exposure limits (PEL) for Air Contaminants. 53 Fed. Rea. 20960 (June 7, 1988). CMA is a non-profit trade association whose member companies represent 90 percent of the production capacity of basic industrial chemicals within this country. Because many chemical industry employees are potentially exposed to substances covered by the proposed rule, CMA has an active interest in the rulemaking. CMA's evidence falls into two categories: one deals with the operations of the American Conference of Governmental Industrial Hygienists, the other focuses on vinylidene chloride. The evidence concerning ACGIH deals with that organization's philosophy in developing Threshold Limit Values. The two articles detail ACGIH's commitment to worker protection and its uncompromising independence. The material on vlnylidene chloride (VDC) consists of a list of studies on that chemical. The National Institute for Occupational Safety and Health recommended in its testimony that VDC be designated as a carcinogen. The attached list of studies show that NIOSH's recommendation is not supported by the scientific evidence. CMA believes that since OSHA did not cover vlnylidene chloride in the present rulemaking proposal, the agency could not legally adopt a standard for this chemical without a new proposed rule and opportunity for comments. If you have any questions concerning CMA's evidence, please call Timothy O'Leary at 202/887-1278. Sincerely 2501 M Street WV Washington. DC 20037 202-087-1260 Teton 89617 (CMA W5M) SL 061864 BEFORE THE UNITED STATES DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION POST-HEARING EVIDENCE OF THE CHEMICAL MANUFACTURERS ASSOCIATION RELATING TO OSHA'S PROPOSED AIR CONTAMINANTS RULE ) Air Contaminants; Proposed Rule, ) 53 Fed. Reg. 20960 (June 7, 1988) ) ________________________________ ) DocketNoH.-020 G raldine V. Cox, Ph.D. Vice President and Technical Director Timothy F. O'Leary, Jr. Associate Director Health, Safety and Chemical R gulations David F. Zoll, Esq Vice President and General Counsel Susan Conti, Esq. Counsel Of Counsel: Neil J. King, Esq. Wilmer, Cutler & Pickering 2445 M Street, N W. Washington, D.C. 20037-1420 (202) 663-6061 October 7, 1988 Chemical Manufacturers Association 2501 M Street, N.W. Washington, D.C. 20037 (202) 887-1100 SL 061865 BEFORE THE UNITED STATES DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION POST-HEARING EVIDENCE OF THE CHEMICAL MANUFACTURERS ASSOCIATION RELATING TO OSHA'S PROPOSED AIR CONTAMINANTS RULE Air Contaminants; Proposed Rule, 53 Fed. Reg. 20960 (June 7, 1988) ) ) ) ) Docket No. H-020 This submission contains the Post-Hearing Evidence of the Chemical Manufacturers Association ("CMA") relating to OSHA's proposed Air Contaminants Rule.-^ CMA's Post-Hearing Evidence is contained in two Attach ments submitted herewith. Attachment I consists of a "Message from the Chair," prepared by Vernon L. Carter, Chair of the American Conference of Governmental Industrial Hygienists ("ACGIH"), and a "Commentary" on ACGIH's TLV philosophy, prepared by Ernest Mastromatteo, Chair of the ACGIH TLV Committee. These two documents appeared in the March 1988 issue of Applied Industrial Hygiene. 1./ Pursuant to a notice published in the Federal Register of September 7, 1988, 53 Fed. Reg. 34708, the deadline for sub mitting post-hearing evidence was extended to October 7, 1988. SL 061866 Attachment II consists of materials bearing on the question whether vinylidene chloride ("VDC") (also referred to as 1,1-dichloroethylene) poses a cancer risk to humans. Since OSHA did not propose to regulate VDC on the basis of carcinogenicity, CMA did not address this issue in its Comments. In testimony presented on August 1, 1988, however, the National Institute for Occupational Safety and Health ("NIOSH") recommended that VDC be designated a carcinogen and be "controlled as specified for vinyl chloride in 29 CFR 1910.1017 with eventual goal of zero exposure."--2 / Although we believe that the NIOSH recommendations could not lawfully be t opted unless OSHA issues a new (or revised) rulemaking proposal and provides an opportunity to com ment thereon, we are submitting in Attachment II materials that supplement the record by providing a more complete picture of the studies that have been conducted on VDC. These studies provide additional information showing that the NIOSH recommendations are not supported by the scientific evidence. 2/ Testimony of NIOSH on the Occupational Safety and Health Administration's Proposed Rule on Air Contaminants, Docket No. H-020, August 1, 1988 at 8-9 and NIOSH Table N6B at 4. -2- SL 061867 Message from the Chair DmtSic pin ofWr. * Awrtnn Conference of Govantnmmal industrial Hyfecfeei (aOOIM) (WMd t aitinbcr of copies of a manwacrfei accapted for pubkcanon m fewnal mma$ dm todwtrial medial ptufemtan. Thk mmnwatp offers what I M to be unfair mack on the Threshold Urns value* (TLVs) far Chemtol sukmncas and tht proecw wheraby they arc established. u questions ih* prefaekonai ethics of soma of die pm and praam amhaw and mwalMB at the cosmmme. i would like tothank our coitoagu* in die various profcmaw who wart adcad to comment on the manuscript and who were Unci enough to supply us with cupm. store the faurnai to which the manweript was submitted did not. Aktaugh the copy of the manuscript wbid) we time received oomaina some feat, a also eemint a penaraua amount of in nuendo and mkrcprattnwion of Infor mation. Some of din infennaiion. which the unMfarmad render would interpret a* fca, k actually unaubaantwad opktion by the auhua. k la not my deaue to undenake a potot-by-poim rebuttal at than time The aOGIH wiU rater* that at an option after we have seen the puhhahed article. The overall thru* of this manuaeript la dtai corpora* consultants hern bad an un due influence on the development ofTlVs. The inference it that there professionals have ridden roughshod over the hauer (udpment of the voting members Mom of tftia hWorlral perspective reiatad to events to die 1960s and 19?0 Akhouph die manuaeripi does admit to die paucity of peericviewedtofasmauanonanumberofcompound* durtoa much of dim era, a pun on to chemr tint corpora* consultant* ma nipulated die available dm to the per ceived advantage of mduvtry without re gard to human hetoth Thu mowat a* ptvpwwl m sarirjmuwy nai At tha tone. the puhiicauun am at tim atanusrnpt at qussnon aw untowmi Obwnk* dm on which to bm a TIV was a fermktoble task to dm wrly w of dm commute* The fin dim much of the needed iidbraimton had bean permuted by. and was to the Imndi of. toduory k acknowledged tn dm manuscript. The comaamec eould lava vary wad taken the any way out mid done nodting to obmm die imedaddtw.ToaniedtoMttodtwry'*po. aWon on retoMing dMte dm to the public during that dm it not now gatmane, in my optosoo. ft is io die commaiee t creda dim k brotqd* m toduetrtol conaukano provide this aousce of fefasamtion. Aa an added pom of tofannauon, an toton km been unctoraw) far tone dm* ramora refereoom bom dm TIV Pocumemation far which dwre k no comptaw report on IHe whan a TIV a reviewed or updamd. The oommistt hopaa to oompkae dm psomss to dm near taan. I would also Hke draw upon my five yaan (IfigO-lfM) capastonct aa CMr of over the value ofacianidlc dm to be uead in namhlkhlng a TIV. This k at k ahould he because I haw yat tosae dm perfect scientific study that a not open to aome queation. However, wkhoutqucation, I can say that Mien debate had ended, voting members baaed their daemon* upon valid scientific rationing One unchallenged fact remain*. Tht ACOIHTlvCoineatoaassmpped into a vac uum and (Wad aimed to hafatog to provide worker health psuieaton Ifyou arc to bebeat the vmiraiorRy ofoccupational haakh profawionali. tha process has tnsde i very MRndkM cuntrtotaion to toduariai health programs. The ertwrta far deveiupmem of TIVi and the Urnnations and direction* tor of reevd for yean. The Notice of Intended Chanpas iiwkes input io proposed charm* to. or dosHopmem of, new values. The TIV Documcntmton, although not aa complete presently aa w* would like on aranc cot* pounds, it a puhUahad bwt tor each value. Challenge* at individual TIM (rum taripgs sources as iietoR mo N0t or aw low are welcome, and hmc straotRhewad die prooaw. om*datty tivsi aaontpoiicd wbh new acMntiftc km. Dfcaprccmam weh die conetpot of "ptomaine of nearly all workos" and of "thrcaholdt" km be axpdacd due to well known philosophical and poIkicai differences ooneeminR that issues Published scientific eonttnenaty by infanned and qualiftad people uo tha proper we of TIM tor heakh pmfaaatonak at wall as Infanned ottqw on their mtowe k appracwwi However, mempes to discredit dm TIV proem dtrnugh unfounded mmek on die professkmal atMci of camretoae Tha ACG1H does not apnlngtor far dm way the comma** operand to dm past or psaaanc In fra, we take grm pride to kt meumso w*m i tok tsaue far your review as* rim cunans TIV Operational CutdeUms and the TIV Documentation Oudtoe (aac IWmiwl rials") and paper giren dm 1M6 Professional Conference on Industrial Hy giene to Savannah by dm cusiwmTIV Chair, meoMamnmaneo.MD.on"n.M:Oiange to Fhilaaaphy (aae "lovkad Comomnniy"). The Ttv and ftotogical Exposure Indiras (BB) Casnoitoaaa will esndoue id respond to the naad far gukkiinas m aaakt dm toduatml hyptanki until a baoar and wore accepted procaa* comes along They will dmn glatfty oka ihetr riphtiul place in hisy Chair. AC01H M ikaw SL 061868 Invited Commentary----------- TLVs: Changes in Philosophy * ^C/TmWl MmrvlimO When Id Briar ha approached me about m Mi FrtiMatonal Conference on lndusuiti Hygiene, I readily spread w *fc on TLVs. I became Chair of the UV ComniM far OMmical Suhnanco In June 19,dfer haring served fa a member and oanwbam to d* cowmifact since 1963. The word pfotoaopby i* derived from Croak maw wh "philo" meaning loving and "mpty" msnfag adence or wisdom. The rnmdom Hotm Cotttf Dxtbnary" define* phitaacphy as followi: The ntional invemgaiion of the irvtht and pnndpies of being, lowwiedgt, conduct. A spam of phtfoaopMod doctrine, tg, dw philosophy of Spinosa. A Critic* eudy of the bade principles and ounetfas of a particular branch of knowledge. 14.. the philosophy of ad- A syetem of pnndpies lor guidance to practical d&dn, 14, a philosophy of kiC. A philosophical, calm or smic attitude. I would like 10 think that the term philos ophy, whan applied to TIVS, refers 10 the ntional invenigation of the knowledge of die dhas workers of chemicsds id Mch they are expoecd k) the workplace for the putpora of mridrig recommendations which will dien serve as guidelines far good industrid hygiene practice, primarily by ft*emmenal industrial hygienuo but also by other occupational health profeadonata. VM> the definition of philoaophy as a> plied as UV*. m. preacnation trill o&m die rariy hleory of the development of Ttvi, the philosophy of die TIV commlMe aa reflected through the prtrioua chairs, and finally, some of my own pMtoeopby In itfanon id new developments The American Conference of Govern* tcml Industrie! HygitnMs (ACOIH) was fine onpfalaad fa 193d foam k> inception, a major concern ofACGIH was the anew men of hedthhnrtis of workers and the fawemd it me Pnfauonsi Conference on Induerul Hygiene nxxwumd by aw Americm Afadswy of tndmrial Hygiene. Hywi Regency. Sranrah. Ccorgu. Ooober Jl, IM6. provision of racommendatioM as guideUnet for the eorarol of ooeupauooel health Btoomfiekr* laa described the ** nnunl meeting cfAGG1H which sms held to June 199d.Theabfea*mafiheeorfei*nce were affirmed fa die conattuian of !93g nd reaffirmed fa 1931. The obfactiras wera fa "promote mfaaarial hygifa* aaMtias . by offidal federal mt facd and territorial Induarfal hygjww MtlvitMe; so encourage die interchange of experience among in dustrial hygiene pcnonncl fa such official organisation*, 10 collect and make accraifbie fa aQ governmental hygienfits tudi rooernuon mb mb m (mf nt a mmm* ante to them fa die proper fiiMUmcni trf VWT OUDBL The AGGfrf baa become an independent organiadon wkh membership limned a federal1 ac, looti, id nrriorttl govern* menfal onuytrttwal health pnafaalnneli, Mcmomrap m md open vo onw ex ihe eademic community ACOIH la fi nanced entirely by Ms memhenhip dues, die afaa of ib publications, and revenue vrovn me nMWiy qi cmuvvmi no symposia The Conference rectoves no sub tidies from governments, Industries, or unions. Only governmental or eademic workers were digit It 10 serve an ACOIH Cocnmtaees. In 1971. die Oieir of ACOIH. Herbert footing*, added non-voting eonBrians 10 die UV Commutee from indus try and trade adorn. Hidtory Of TLVo The fate Vdkaei C Fredrick,'*' Director of die Burafat of Industrie! Hygiene, De partment of Hakh far Deuoft, anended d>e third annual meeting ofACOIH in 1940 and adad tins question "May l inquire wh commfact, If any, fa dria organiMtion is responsible far die eaabtiahmott of stir Units of threshold Umfa and ooncenmtionrtn 1941,asubcommioee on TLVs wa esuhlished under the Commute* on Tech nics! Standards wkh Fredrick fa the Chair Fredrick commented to his subcommittee: 1 feel that our Subcommittee should a ume an active petition fa the asrtiriitiv mem of working Uitriu and should issue a km annually, so be revtaed cadi ye* a a medical or tosdoofafical Information peeo which deerty fartlc** fae need far revision, thti an be done wgfi ear die annuel report.""* fa 1944, the TIV CommrtKt became an report of the TIV Committee recom mended 130 eesumum ailowtirie concen trations (MACsl The MACS beamed* TLV* fa 194S. ftedridt nosed th* ACOIH deerty resolved so sepem* TlMs from legal coda, fa 1966, he went an a outline Ms philos ophy the ftm Chakon of the TIV CommtieB "Ihe philosophy of d* TLV, a es tablished by ACG1H fa thaw eerty days of eur prrdsBlnn. ha remained aubefanifally unchanged *id dapee osrpfag, ertfidem, ua, for baar or earse, e accepted an an faamciional baafa a the beet emiltirie guides for pnrridHig heaftbfiil occupa tional envifonmem for she woffam of the world. "Akhough the perfeo TLV, Ma the wdlo'-the-wiap a the pa of gold fa the end of d* rainbow, anna em be retiaed, fc lemtins the bedtbonc of succe^ii indus trial hygiene practice- tvonmelly e will know enough refine the rah*, make faio account the tuiepdbUktoe of numerleally impotaa gcnotypeA jhe eflboi of aynergiativ and the advem faflueoce of concam rironmoealiema,baldoifat dweoar elimine* d* need for the axperiergfaniai fc 4gmentofdwlndu*ralHyno* effective application."1*1 Stoking. ^rvedaamemb*ofd*TLV Cotnmieec for 37 yean from 1931 to 1978 and a Chair from 1962 to 1977. feotir*'s fatng ability, tod his dwermburton 10 gw d* |ob done, foofar^er developed fas op erating prooodutea of d* TLV ae.TM He pulled togaher a TLV i In faduwrfal hygiene. ogy, pathology, cpsdwnlology, and occu pational medicine. M nosed aerifar, foo ting* added non-vexmg consultants from Industry and organised labor on the TLV Ml AAAtdO MOUCTfali MfaM OSS Ml SL 061869 eunw*PMM**nr*Tur Under faofonpr'i QmrmmNfi. the phil* oMtdiiai piriropfcsafthe TLV Comnuuce wc* manned up to da vribm preface to d* mommendtil fofato- 1ke pMie- TIV are IniHi todirt weomnandedo dartcd faa* mtobnam of the eadbhle pubhdad aamlftc mfermadun from mudtot to apoaed human* and from awdte> to mpertavtnul anioak dor each TLV, dare b to be a ptddbhcdjto^^ TWim lined on s beUto a a thftaiv (MQ Qr BWmV Oi fO^onv TObw which no advene health cffaa vmwld occur to worker*--todudUtp dw tocatttd "preoxaT threshold* for area- m* TLV* rate to afcbona conctmtrmioni a which "ncarty til- worker* may be expuad for hour* per dby. 40 hour* per week for a workine lifetime with out advene aflea Some noriter with todivtduai moapdbifay nay not be pRJHBOO D) Oof IUORWWQQB TtVi TLV art not a he repeidetl a fine Una bttwwi aft and unaafc eondittona. That' are guideUna* for we In da practice of mdunnaJ hygiene and Mould not ha wed ny anyone tintrained m da held af ktduatriai bypane. H.V* pre derived a an open proom. Bccontncnded addidon* or amendmens tn current TIV* art placed in a provatonsl Hat, da Nodee of toanded Oanpw (MOt). for a minimum period Of two yarn to allow for Input by all Intcreded peitiea. MO are phen pub lic notloa in praftainnal puhbcaiana. Die TLV Committee meet* arid) inar med prnupa wnhtnp tn praam a point of view PhaU)', aa noted dm*. da reenmmendattona of the Uv Commitice ere publiahcd in a apodal documynorion which proridaa the artentlfk fan* far the ludiiment by the Commeae. The TIV Commawe defined duet ou pDrie* of TIW; tlv-DW--da time weighted wap concentiahm for a normal P-hour anrtday and a 404tour workweek, in which nearly all workers nay he repeatadly expewed, day after (toy with out afoame dfoct D.v-flU^A lS-mimitc time-weighted dverani ettpaawe which dtould nm be exceeded at any dme durtn* a work day even If da B-houf ume-vxtphad averse la wkhto da TLv. Expoaurea a die STEL ahouki not he lonpar dan 15 minute* and dtould not be ftpowed merethen 4 tamper dm' DwmhookJ be at team *0 mlnua* bmwaen miccetto* exposure* a da STEL TLv-C--The eoncerandan dm ahnuld not be ettceeded durinp any pan of the ImurMon PMtoii and StELb In da aerher adetons of toe TLV Urn, ex cursion ktnim far the TLV-Tfots were imed on da aha id da Ttv-tm. The 19M IK enmeiiad thb nop* of permtoud excur- TLV-TftK 0-1 1-10 10-100 100-1000 Rmor 3 2 1.5 1.25 The TLV Cummktee knertb in STEL* wee apwrlad by da putoUcaion of Pamayivenia * Mon Term Umb* (STla) fa 19*4. Fenneyivaiia adopted 3* STU in 19*4 and wi aJdfoonei 50 m 1065 Patnayiveab publtehed a Iw of STU for about 100 aubancesfor exposure* of 5. 15, and 50 min urn**' In 1971, da Executive Board of A0GIH mquemed da TIV CommWce to ewwlderSTlUtoibvtpulMnetiolndu*triel hyplenbo in the manapenant of brief experience* for airborne apenb, wpecktlly dtaee which cause irritation, kievumblt dame damape. and namab. The TIV Comrtbee act up an ad hoc praup to nudy SHU. After ha review, tla TIV CommMee amipned flVL* to 425 TLVi, 95 were canakierad to need fordwr evahation. In 197*. da PTVLa were added to da TLV kat undv da Ncalee id Intended Chenpm In peneml, da documcnution for dteae STEU wa* kwdequaa and man}' guamotu of (nterpreueion were retted by kidtaarial hyplcobt* In da Odd In 19B3. the TIV ComuMrcc earned nut another re view. All STEL* for which da published dma were werit or laekinp were teenm- mendeti for deletion. Tody-Sm* win only be recommended where there b need far dam and where adentiftc documentation b rwHai>lr to mppon them. The current TI.V Ibt prtwidea the prevent concept far da new ctaunuon lime nm ommendatlona m foUotaa "Shon-term excurstant ahould excued rime time* the TLV-TMfar no more that a total td30 minute* durinp the amrit dm aid under no efttunv the DV-TWh. piovkled that da TIVDM b not eaaadnr**' fohaaewr da toatlcnfaplc tkea far a Mb edic atfomance are avtttoble a adA* a pTtt. fob alia take* precedence ne da escurWon Mmfe rapardtom uf weadar ft b more or lea nrinpent. The lddn~ notation area added to the TLV IK maneuendamdnwfapderief. Thb no tation refers the poaemui eomribudon to da overall ddn tbpoeure cornea with da chemical tpem. The noation tt added on da tab of da Gnmmna*'* judpmem baaed on da publtahed kteraui*. The TLV hat alan pruvtdad tafonnaion on: Otopailanel expoeur* to miaufei of two or more auhatancet. An tppendix Mm mamplei of how m apply the for mufoa for nMauret Ntdancc duau. ttapfo abphyxanta. UbM and Hbum o( TLV The pafoce of da D.v Ik conamed number of recommended proecripOona In da ua of TLV*. TLV* anr not mended for aa in foe following caam: In foe evaiuadon or control of commway air pollution nuiaanco foammafopthctoxlcputerxlalofeontbanua untmarrupad (xpoaurea or other extended *erk periodk. A* proof or dbproof ofan exKfop dbKe or phyalol condldon. Pnradupbnnincoumrieawhoaewutk' dip eondkiom differ from dtoae in da UnKd Son* and where aubrnnem aid prnoaar* dtffor. For maty years, the TLV Cumndnee puhHahed a baanant tn da TLV |k ahout foe aa of TLV* in legal codex. Before 19D. da preface contained this atatement: The Conforance dne* mx corwder tha TLv* art mpeopriaa aantr far r^yphy* ht |ppl coda* and lepulaiKxi* and lecomnandi Mfomt nadt we. If the TLV* ere Kid (to lepai cudK) da men and concefi oondkned to da preface dtould be nafoabad aid proridom made to hup da Ibt curiunt" to IfTl. da Oeeupakxal Stony aid Health bfontoMnilun (OSHA) pramul- praanafority ofwhich were dtrtvm from kM SL 061870 tor i960 TLV*. Currently, the TLv booklet curtain* no iwukiiueixfadnn show the ure aTTLV* in legal cotton. In rctreapea. It may have been unwise to delete this eatemem from the preface- wwnopvw In 1972, ttoUVlk included Appendix A which Itoted occupational carcinogens. Carcinogens ttt catqpraed at follow* At Human arenogem a) with an assigned TLv. b) whhout an assigned TLV--no ex* poaurc permitted by the man sensitive measure. A2 Experimental carOnunerM There chemieito are capable ofcaus* hat turnon in animal* and ahouid he reprded at potential human careuv open*. Exposure should he reduced to a minimum. In recommending TLVS for curunugem. the TLV Committee was, in effect, giving rec ognition to is belief in (he existence of 'priKiKat" thresholds to these carcino gens T)w risk to workers exposed to con centration* tiefow the TLV are cotuktorrd negligible In 1976. an addition to appendix A pro* video the TLV Committee guidelines for the classification of the potency of animal carcinogen* In me 1966 TLV lot, the number of car* cmngen* In each group was as follow*: Al (a) 0 substances (including 4 forms of asbestos) which are assigned a TLV Al (b) 4 substances without an aa*. signed Tiv A2 40 substances. 13 without an a* signed ^ v In 1903. an ad hr .Tomminee was setup under Dr. Hubert: nas Thu ad hoc Com* mume considered mat TLVs were (uttlAed for some areinggen*. They recommended that two categories uf ocrupauonai carctougens be included in the TLV Ika.- Al Cnnlirmed human carefongans A2 Suspect human carcinogens In future editions of the TLV list. Appendix A will be amoved. Individual carcinogen* will he identified to (<c mem lea wgh the Al or A2 cfcsigKXkjn as appropriate. All sulreanres listed as Al ur A3 carcinogens will he (toted in the published Documen tation of the YLVa. in addition, the daaaification of the TLV Commioee will be com pared in a tabular fashion to that of the International Agency for Wureardi an Can ccr, dm MaK Gommtasinn of the fcdea Acpubtic ofGermany, the Nmionto Institute for Ocagmtomel Stotoy and Heath (MOfiWL fo dm National Toxicology Program. The TLV ComitMMC la ewere dm there dresi* Acationi are irw 'txnpanble. Nemithtlen, tonaeusnw dm nv ck vamey be able to review mn and meommeodec ctpoure U companion wkh thnat madebyothc. , -**. This change in the hentilngrfcaninugtm represent* a mafor mw approach. M precdoti phtioaophy, TLV are guide llnea to be ueed by occupational health profoeatoneto. In ewcncc. dm UV Oommmae mamhersortyow aerttkad review ofthe Ikantoire far a specific chemical cow wing such pokes a* ftomrd IdretiAcatioa Exposure MMsmunr--both human and animal. Dore-treponre aaaeaameni Racommendations for workplace ex posure. One could my that the nv Committee ap plies risk assemment approach in apply ing u prefomtonal todgment for a rec ommended nv. h is up to regulatory Mcnoes m apply the appropriate aoctoi. economic poUdcaL and other factors in applying the rceommcndadnns of the TLV Commioee to legal codes. Biological Ixpoourt tndiooe In 1967, Herrey Kkiiu, a former member and Chairman of the TLV Committee, pub lished a paper on biologic TLV%r In this paper, he dnofoed a primary biolugical threabokl--thebfologieal enneenawfon of an agant ai which workers would not incur any dfctotitoy over a working Ubtime A recondary threahokl u defined aa that btotagical concentration whkh, If maintoed. wt0 invariahty lead to dtoeare Etttins Idled foe 393 TLVs in the 1967 Hat. totdwMg thure for which he feh urinary NMngsa! TLV md thnre tor which blood B TLV* would be appropriate In 1973. dte TLV booklet made reference to the preface x> biological TLVs but none was IMed. In 1900, the ACCIH Executive appointed a lVmwnber working group to make raenmmenwnora on ntuvopicu mumtorin^ uf workers. Tht* working group reported in 19A2 and recommended that the ACCIH should develop hetJugkal 1LV but should rex become involved in medical aurretilance Btoiogical munfemngwa* defined m the evaluation of workplace exposure* k> po* wnoallv ode ihwmtak by dm mtf-- mem of 1) Specific dtemical subatancre nor mally found to the body, but which can incure* foam work e^enence- 2) Substanm normally ahrent bom foe body 3) Substances remdung horn art d by a hsxhemtcti regponre t mogBKM tofluencaa. Biological Monkortog la not nreemirUy a memure of mmcky but a mreaunr of ab sorption and meahoUam uf ww industrial chemical. The working group recommended thw a new Cummmee he esubitohed de velop btofatocal TLV*, which were called Btofaglral Exposure Indicts (BEU); the Chair wm Dr. Vkta TTtomm hi the 19B6- B7 TLV Hat* thare e ato adopted Btto and n pieced on the "Notice of Intended Chwige." The BeiCommtore defined Blto 9 riuqwr. iv m npvcm o suffer any (U effect a* long as the described measurement of the determinants are maintained wtihto the tonka of the rec ommended BEfe.""* Currant Ibbubb In fMaBon ts TLV* The use of TLV* In deriving air quxitfv aandard* k wkioapread daaptie the TLv Commioee recommendation against their ure m tor polhition guideline* or There is some pressure id develop cnwrjrncy aponjrv mo nr gqrv munky reixtema to caaaa uf todustriai actodtna. c*, spill*, fire fighting, me. ThtACGOITlVi had raoehad wide toatmodonal recognMoo. in teen yam. however, many countries, perticutoriy to Wcirem lumpe. had begun to demip imvovw uiuTNnm tu rvccxn* inend ureuptokkiel exposure Umitt. The ACGtH mtontam* a Uaknn member of the Genian MAK Commiaaioa In 1905. ACGIII sponsored an international meeting to dheum occupational ex posure Umk*. This meeting stimulated much mtercai and an interna*lorn! Mooing commioee of such organia** mm* wa *et up wkh Dr D. Honehler of Gamonym chair. > The TLV Commmre W imwing towanto pantote-stoe-mtective sampling enmrto (R&kTLVbX fonidK will be dtvktod tox> three eamgurte* determined by thetr loato of action: 1. irwpkMde pwticuiatc mmaTLV* (tkMTLVk partides from > 10 to 50 *m muumutimu.mm*m m SI, 061871 MB 1 Thomdc OFH-UV) nith a mean moiftamte diamaieT of JO iun * 1pm. 5. imiirififl (Wd-TIV) ndh a mctn mrodynam* dumper of S-S pm * 0J pm. H* paa k noenmdw nudy toy Hie tmU\ A TIV* mfl be taaiA band The Tiv CommAac mil continue to be independent and repeteentetme eT the ptofweional ildila (toduamal hygiene, toa- Icoiqp, occupational methane, end ^t- Akentett noth idtodutaa ere comWIJ||| ijiLiii >1 air - irtaipni imermi Sadr" reconenended a ample ap proach to a Tiv Reduction Actor far enefeamne enrtoMft a* toffon* The proeeae oTdevelopingTIVi mB con tinue at an open ptooaai The TIV Com- mtoee publiahm an append*. Xhamieal Bubrnmeea and OAmtoam Under Study," much ton the wbmmcaa and araat b u tomraaiad to aid toquet input by tmer- > hotuaoffaorit hourmorhed K Par a 12-hour day, Ac Uv deduction tooor would be tar e mtotowm of mo yearn far eommoat There la e pubUahed doctenemadon gmng Ac baap for A* rocwmondtolon to Ae A j|.lnv ,* Tiv Cotnmmea. The Tiv Goanmttee it currently com- The TIV Committee p reviewing All priced at l) eUgfele membert from gov- qumdon. mnmmm miq hmwi no y sousvum Many of Ac TIVi far toiublc and A* from government.'Adury, and oqpnlaad DOT. AS QOM WSV, BIS HRMn VI eohtofe compoundt arc lUMd without Mpraaemathet ot vartoue dupllnp and q'dafaltianofaotobfeandinaoiuble. wiparm to occupational heahh. There are A definition ofdolubUltyaa greater Aan 5 Tubcommiiaeat to addition ipadel 5 percent m water u not oomptamly mtitibemry. The Tiv Goouruoer m re- nothing groups. The tot Conunmot taawa imee yearly The Suboommtaoti alao mem vtcotng Alt and mil probtady Hit Ae aohAic and totohibte eompounda totended to be cowed by Alt term to Ac documentation. tmee yearly- AH noth a done on a mb teueer beak mA nhmnuomvt and ctorioU tupporr from aOCZH. toemhen are at- mad to travel amt, but eo honoraria are ronrtmlon paid. A metoffote tor Ae Commtoee memmi dinm Pmroem pnpviNB nmM oogurmt The owtmU phikeopby of the TLV Can- done for ant or fevked tuhaencea. Thk miner hat remained unchanged from that oudtoed by to founder*. Tiv* are mended lor Ae guidance of occupational htehh profeaaionaU io aaala them to die control require* s major effort at then are currandy Aw 790 aubanem Ikied There arc current proOicoM in Ae mltuae of TIVi over which AfConvninM hat ao cotaeoL Thera to of comae, dto^rec- UVCtanmtroe bated on kuEpiaetoon ofAetoeretuie The current phtioaophy of die Tiv Cam- atinee lemam nnrtaiiaart tram dm out- recommcndment of Ae Tiv Commtow ere ttdl of mlue to Ae peecdctog todeaittl hygltnln to promoting At hmhh of mart en taAeUnfcedtoaim endowed. 1. TbetondomHwColaeeOiBigmry.L.Urdteg M-The tondem Home toe . Nan Xerit rwm I Plaatotata. mm the attHH Het Pane tor tadvmkt Hnkee. Am tod Hjq amoc. J *55$ OMdX . toadnek. w.O : Tjae^totA ef^Ae MOatH 0mm. Turn*. StohAMtoMeetoto tdAOQW, iter U-14. iNd. to imito NO; pp. to-45. accuiCtomwmdMi). 4 toatonger. HX: Hodut Operand! of Thrert otoUmut CommtoeeefaCCM.Ant tad. iqtAmoc.J 2WKHAX Term mm (iM5V 4 Amenan Ceatoienee of Ob immn--t to- ACODi. CMctonm creeix 7. fftona, Hto. teernory and Moleale Thieatv tod Umm Am lad H)*, amkJ. MSH (Mn 4 grief. U; fcah. RA Owumtiowal Itpwn Umfei tor NovelAoiKSchedule.Am. to4 Hy|. tome.;. 54447 (IPIS). Or. Umrnmmeii Chair of toe aCOM TVatoold Ume Vduet tor Omnucal Subnaeem Com* Si 6lS?2 Attachment II SL 061873 BEFORE THE UNITED STATES DEPARTMENT OF LABOR OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION CHEMICAL MANUFACTURERS ASSOCIATION VINYLIDENE CHLORIDE PROGRAM PANEL POST-HEARING EVIDENCE (Docket No. H-020) In its testimony in this docket the National Institute for Occupational Safety and Health ("NIOSH") recommended that vinylidene chloride ("VDC")(also referred to as l,l-dichloroethylene) be designated a carcinogen and be "controlled as specified for vinyl chloride in 29 CFR 1910.1017 with eventual goal of zero exposure."1/ CMA believes that these NIOSH recommendations are not supported by the extensive existing data base regarding the potential carcinogenicity of VDC. While action on the NIOSH recommendations would require an entirely new rulemaking proceeding pursuant to Section 6(b) of the Occupational Safety and Health Act, it is important that the record in this proceeding contain a more complete collection of existing studies on this issue. 1/ Testimony of the National Institute for Occupational Safety and Health on the Occupational Safety and Health Administration's Proposed Rule on Air Contaminants, Docket No. H-020, August 1, 1988, at pp. 8-9 and NIOSH Table N6B, p. 4. SL 061874 Accordingly, CMA submits th attached data and valuations, together with a bibliography of other studies that must be considered before OSHA may make an evaulation of the carcinogenicity of VDC. SL 061875 Exhibit A Exhibit B Exhibit c Exhibit D Exhibit E EXHIBITS Norris, J.M. and R.H. Reitz, Interpretive Review of the Animal Toxicological, Pharmacokinetic/ Metabolism, Biomolecular and In-Vitro Mutageni city Studies on Vinylidene Chloride and the Significance of the Findings for Man (November 5, 1984). Quast, J.F., M.J. McKenna, L.W. Rampy and J.M. Norris. Chronic toxicity and oncogenicity study on inhaled vinylidene chloride in rats, Fundaro. AppI. Toxicol. 6:105-144, 1986. Quast, J.F., M.J. McKenna, L.W. Rampy and J.M. Norris. A chronic toxicity and oncogenicity study in rats and subchronic toxicity study in dogs on ingested vinylidene chloride, Fundam. AppI. Toxicol. 3:55-62, 1983. NTP Technical Reports on the Carcinogenesis Bioassay of Vinylidene Chloride in F344/N Rats and B6C3F1 Mice (Gavage Study), NTP NO. 80-82. Bibliography SL 061876