Tobacco Documents Online

MNR- 1 7'-•D± bJELI 14: 37 0 F° t:ru),G?Ffttts O( H~WARD KICE NEMEROVSKI CANADY F,0a1EIZTSON li/:Ff' 11...K- DEN7S T 1lCE . HO1iAlitllx SYJA)h()v.Iu'. Rri7lnliU) r' q~Ye:»' ~ 7AMk.SIRmNY.T[wfA~ll URf)M.: b /f1:A. IR' MA'Mr1iNlT{ ~MAnS~ MJUl.MY'~.t.: C:c)UDluN~. FM'. MAYaNi1 QL'(iK' Wla!1tENCT"B MRkIv S'R\7.M l MAYY~R Jr,MPO L ~ :Uft•~ ntRJC M. K'JiV~7Ci:A~. R10MAS n :1ULSYV llll/!~N ttt.v;~Zrll r.. M/11:W1AN IenN C rtora• RwVp04PM M WXilIAM,.N... DA?.4ALfl Y ~~ Mlld~ Bt)MRT R' MrtS[.": H JpwM II G::dLRT~R ~tlIrYTA~. tutA'8t:1i s ~ALVt5qa' H . MA3TSLV ?4001tE ~. PlTml J. SUStN RmNA/.(J. M STM ~.. oANRiL 1 i olA"NtKt ~ CZL"]AM M BOYO: 6GALDiP ~ 0OOkfiN MY'L ,MOp.~SLA4: J!'FFR!'Y L .4CHGi?ER'. UNUA VDRE-1LF:v vA1IK PI Wr1A11IYy k/t;1µYl)I!' JN;tnM~~ A1A"~ u` N'AIV V T)// lkI'•I ~. 14 ~'111Y0'.1 '.'SNRId;S ~k~~ l)RTTy~S I:Ir " TT R (l<)f tav ~. •TSMRI~% ' UITUN k~wlIr lf: 4AKfl1A K~ CI'):h1IN/:11A.^a' 1SMt,,nlb'.' M'-cANN WtMh' I M611ER IA.rT A ~ NexC)N ~ NIM.YAItt)'~A bII IJ,UIiIYVQ 'Y~ Yt'UFRxw i rTTtA,v P '. IL(:~.Mt'UNAv~ /% )N4IUIN ~ xhtM1CR' r,"Y Vik . W f4l.7~. ;OM.% ~.vP SGHW:UI'!L°, TqDCY THOWyOV. MElJI?tC~f. ~MO/VttSON~ M IfA7NCU.'nUY1fl. ISNOA' A ~. M/1ARY, Cutpl„R~ DCMr6ti "APUA~ C ~~. rAAQfu EA7IEJJM ' A ~. v)NT4,R5 MUt7ert~[ C".pR' `TfYC:'r'M i t71C"LAr7`+"~ 6fR1STt11N/t,W T~ Mforcfh~t D.vtO: UN.SCtr eiiIUBERt M -~AeK1 IhNKr I. pVA!.- IY.NNIALR L UTAr,:KMAN tY1.CJt.A, MIIIIP7. AARUN'~M~' ICNN.,.1W.. Ntli~h l. t'<)hMlIS~. I INO)A l. ~ H1S o•ARY+~GUt:2N: wn'iMICI 'Al,1)N, IMRA4:I~L'~ NAmM YAMYIA~\ M)11A'N% ~ MIDhNIl. G MOC1~ I,MII.Y A' 1'1'ANY I.AIV'PM~C~. AUtK:NN~N~ x)tllr MIl1/AhNDN~ ILIuliMa /. CH.T'CR"Y YMtl1:LA,[ FxaUArk ~. 10!6M}.:'W A~ 'WAIY', f)rN.9MH A~ WPI ~. v.L:.R RAf.L'M :v,v,SC,I vwt4.11N~ R)(:71A9W A MAR4:AFT)NS<p AUOIUY~ , ~f.ARYIYLQ) d'Professional'Corpora tton ThtRlrE F8tBA8CADERD dE:nR SE11E'R71', FLOOR SAN pRAYVG]SCQ, CA ,91'tt t TELEPHONE {1S/43!t-1600 FACSIMIIJE 414.r599-3041' Carol J. Henry, Ph.D. Director Proposition 65 Zmplementation, Office of Environmental Health Hazard Assessment 6'01 North 7th Street P.O1. Box 9427'32 Sacramento, CA 94Z3'4-732A fllBi ~l 9L;:aL•;Nn~l v ;ONN~ i. CIC1SHty)l17 •iNC ['~ MC'OC:L'~. NG1tt'A71D :ANKN~ MRNIA A. R<1'Y'L~.~Cf 1t;AY/1NY"1 M hrLVOw DA^/tD A ~. BAY,A)R. a!T'L/R JAICM~ .NICiK:L( A ~. VAXJ,4Q' MLLN' M. OOWN TFiDILLt'M !6*Id! M*AW.G. eACX~ i7r''Q+ M DRLSCOIL c6oKre I.. IRfYn 10BGtT'. B'. Wve' ArNCTS!1 MUUT March, 4 , 1993 MATTNI"V ~r~ Y'E!0 FMI I . TMLTol ~ tvJCuuavl /ICN11N'R' IIG)lDARU ~ titi"IltlNM T~ MI.TTqN. 0.UlW i M MN4)OKll. 'rwwnr~.. ~rwn.+rt~~^'~ wrue.r+l'Cd4`~'^~ riPG tARKrLATA sLKft 470 IR VLNC: C.S .r:M TLU^JNdrt'I/V11lnMK). rACSUm1 nu3Sl-nn) Re: Draft Revised! Pro%,o'sit,i,on 65' Warning Reaulati4ns Dear Dr. Henry : These comments are submitted on behalf of The Tobacco I,n6titute in response to the above-referenced draft regulations. For the reasons set fort2ti, below, the Institute opposes the draft regulations, and~in particular the proposedirevision in theapproved environmental tobacco smoke (ETS) warning. Revision of' the Warning Regulation _ is Unnecessary - . The Proposition 65'warning regulations have been in place for over three years. The regulations were the culmination of a lengthy, multi-staged rulemaking with extensive public input. The regulated industry has' eaepended major resources complyingwith the terms of the regu'lations, including theformat, method of publication and content of required warnings. The proposed revisions in the'regulations will impose substantial additional burdens onlregulated businesses by requiring changes in the placement, format and content off warnings. Substantial public and private resources will be consumed in the rulemaking process. There is no evidence that would justify the substantial costs of the proposed revisions.

MAR-1~-33 LJED 14 :-ae 0 P'_ Ci'c. Carol J. Henry, Ph,. D. March 4, 1993 Page 2 Revision of'the regulations is unnecessary and would be, counterproductive. The Dr'dit Revised ETS Warning is Uhiustified Draft revised section 12605(d)(4) Would amend the current approved warning for exposure to ET3~=by adding the statement: "Certain components of tobacco smoke are known to cause birth defects or other reproductive harm."' This addition would require changes in all of the ETS warning signs im Califor'nia, at great expense and with potential public confusion. The ciontent and,format of the current ETS warnings were explicitly approvedby the State, and thousands of ETS warnings have been posted in reliance upon that approval. Nothing has changed to justify a revision in the ETS warning.. ETS' Has Not Been Listedias a. Pteproducti~v~e T_o_xi~cant California has not listed ETS as a reproductive toxicant under Proposition 65. Nor has any authoritative scientific body recognized und'er Proposition 65 made such a find'ing,. Moreover, ETS was not identified as a priority candidate for consideration as a reproductive toxicant by the Proposition 65 Scientific Advisory Panel (SAP), in the list published by the California Health and Welfare Agency in January 1991. The Draft Revised ET'S Warnings is In+consistent. With, the ,Regulation! of Mixtu es Under Proposition _65 Section 12601(d) of' the proposed regulation, which incorporates current'poliey, provides th'at "(W'3he,rever identification of the listed chemical is required by this section and the chemical in question is aimixtu're, includiing, but not limited to, tobacco smoke and alcoholic beverages, use of the name of'the listed mixture is sufficient, and identification of the individual listed chemical components of the mixture is not required." The proposed reference to. "components of'tobacco smoke" in the ETS'warning is inconsistent with the policy reflected in this section. It is also antithetical to acceptedscientific principles. A mixture is not listed'merely because it contains a chemical that itself is a carcinogen or reproductive toxicant. The State has listed only'ma.xtures that, based on its evaluation, are "clearly shown"

t'fAR-17'-93 WED 14 =3-9 0 P'_ E?7 Carol J. Henry, Ph.D. March 4, 1993, Page 3 to cause cancer or, reproductive toxicity, based,on testing of the mixture itself. : These are essentially the same crite,ria that the Food and Drug Administration applies irnidetermining whether food additives containingialleged carcino+genic~constituents should be, regulated under the Delaney Clause of the Federal Food, Drug and Cosmetic Act. These criteria are also consistent with basic principles of the toxicology of complex mixtures'. The tox'icityofconnplexmixtures~cannot be reliably inferred from the toxicity of individual ingredients. Even, well charactearized mixtures may'produce effects that cannot be predicted from the toxicological properties of cons:tituents. Constituents may combine chemically to produce new compounds with different toxicities, or may mask or dilu'te one another's toxicity and thereby reduce anticipated effects. The Revised ETS Warning d is Il3ocrigal, and ngrecedente A requirement for component warnings in connection with listed mixtures would establish an absurd precedent. Such, warnings would' have to be provided for a wide variety of' mixtures or theBtatewouldbecomp'elledarb~itrarilyto~require component warnings foarsomem'ixture~sand~noto~thers.FbrexamAple, the following mixtures that are listed' asicarcinogens, but not reproductive toxicants, undex Proposition 65 may contain components that are listed as reproductive tox'icants: Ben;zidine ba'sed, dyes Bitumen's' Coke oven~emissions Diesel engine exhaust. Gasoline engine exhausts Residue heavy fuel oils Soot, tars andimineral oils Unleaded ga'soline! N Requiring component warnings for all mixtures would be ~ cumbersome and confusing to the public. On the other hand, the ~ ~ ~ ~ ~ ~I

,'MF-4 R- 1 r-~-= W ED 1 4: 47 Carol J. Henry, Ph.D. March 4, 1993 Page 4 selective imposition of a compc,nant warning requirement for tobacco smoke alone would be aroitra.ry and unjustified. 3a ~;ectf'u11y submitted, t DONALD F. MILES' DFM;/ bd 0304'93/'f'-59090'1: A101'J68Y145G82

~ -rira,R',- 1 7-st_-s LJErn I 4 Carol J. Henry, Ph. D. March 4, 1993 Page 5' bcc: - Clausen Ely, Esq..