BiPtechnolopv and its Future Pot~ti~J for TmPrOVqm~(lt Of the Tpbacco4lant A eaper to be~prescg~Cd by B~~Heard a~.~~Tob~cP Exhibition, Beiiing 23, SePtember '8f Introduction A-Q It is appropriate to begin by identifyiq in what ~B~1~L5~ to the tobacco plant ate sought. There are It least ~i~f~3~gg L, B whom the tobacco plant has importance - the farmer, the cigarette j C manafaeturer and the cPns~er, t~I~er~g the aain focus of tobacco o~,~t hu ba~ - E~ihlUmI Ilt~ 3 $ ~phave dPrinsted. ~a~-t6~L? t~zw h~J~h a, ~0~~alr 1~ dlk·C~ ~LH1(4~i~y · ~4 oc~p~~ 4e O** ~~~nc(· o~l I; ~-~J· C~C~c~ I·P 10 : -___. _.~_1" BATCo document for Legal Services : Health Canada 21 May 1999 ·2- it vill be of ~I~i~ ill the future development of toLco cul:iuars that the smvi~s or h~t~j~~ ~f~t~t~ that is for the production of cigarettes. Consequently if v~ look to the future improvements in tobacco they ~ly~ tB~B~9g~ (offFring benefits largely to the grouer) but ue can also 1ERf ii Lnle~ ?D IPL dLVdPP~dl thf ~m~jy thl ~i8111:t( ~i~c~N Pd A IFX~' panufacturel or ~;`~Lt~5' these 'dcunstreaol ~rSh~r~ attributes are recognised as the consequence of proxinp, harvesting, curing practice, leaf maturation and blending of tobacco. ~vL ~Y (· try ~ Ik4'CsaC du*nkJ~Q1,~ In this respect we must acknowledge that any attempts to achieve ~odificatians in tobacco leaf genetics that result in downstream t3 IEPR ~ ilJIOYOPLnti dll plll.f ~6~ I~ I BATCo document for Legal Services : Health Canada 21 May 1999 -3- lr There is I eppdderlble body of ~1~4~ t''srclt ;blt diiferent biyp ~FI~QeE~'LLY~i~~h?~ZB on the cnd ~d~c~f?i~a, lal this pesItion it vould be naoPIYe to rn Ir B~tl~iP~II~ bl·f ~Y!f ikl Il~r~l~ ~b process Is further e·lllcttad by the influence of ~E~jp~M~1~I~ff~ ~ji~J~Jf~;c~p~r~;rqi~ ~tb~~ as thc ability d I Cat ro n~od b its eaironept is renltically bored, The ~L~F~iis~.~'cli~i~ij1 )rDvidl 1 cna oienablilU technologies thlt Ircrlte a~i~ *d a?; tobacco Illlt lal~cl nar to ·dcryil ·~t aipcctl,i tobleel lni and product (Illlticr ~~:~l~*j~PI1 ~ I~jjil~3CFj~yi~ql ;ia!~~~~ P~q!d 1N B~C6 document fo~ leaal Services : Health Canada 21 May 1999 -4- ~cttruaLccliS. Po: ease Pi preslntatien and discussion, ~d~~ iZ~f~Pnt~P~t~'ze" under ~p~f~ms~;b~dinec~ ·B ~ plantbieedinp bZI cellular and tissue culture technologies Iplciii~ g,nctic LngineLri~ 1~ lalecuiar rechalilplies; gene rmppi~y S)abiPtic soil dero-oraaniim iotetetian. b~-~olP~ They should he oonsidered an an ~ltrd~vbo~ and not necessarily as discrete or isolated processes for plant improvement, for instance it is ~tB~toU:tbat·t~~;p~!~~~?~r~f~g &IEP~i~-~-~E~t~B8~91 result in a crwmerciallp useful innovation aithout recpune*t~·d, ·cPpventional plant bteedf~ Indeed as a note of mit should he stressed thad;iPveltmcayio the ~S~red Mder!li jC~ BATCo document for Legal Senrices : Health Canada 21 May 1999 _· -5- hioreeheoloxical be114m ~~~ and that bat exists FEYCS thlt scimtists villlturu to these teehnisues in situltians where further jM ~~, ~1 %3a~8~s... .) ,,,~,, ~:~;t~:c;a~~:~:~pt~dn,~ i biotcchaloa vithil the eontat of plmta there is m ~~~:P~ql?s~gp iDportlnce, tLt of s~j~a~Fj~;~f~-~o~g~cnl their Inrcrlctipn LetPeal pl*t ~nd rhitolplcre for cf~ci~~~et~i of tr~ce l~ri~~ill 11D$ dieCUa9(dd L*~ s ~~i ~diyl P~rr ~s*e ~ ~ ~ ~pPP i" d' ·~Uk~~ bC~~daa ed bee cf~frrq~olb~cr the i~pro~awnt of eBriculturally ilport·t P Q VSE FLI P crnps. The praccss relies on th~L~ib"E~l%i~a~ III~RTc~·~ ~~ s~Se~t~i~t~l~i~Itll~iittributes O CBeerl ~~ 1~ r~rtir 1~ )Irf!~ j O :iru ~~a. ~·· 9 BATCo document for legal Services : Health Canada 21 May 1999 -6- :o~c~urs k:~i iY*''C~*-r'lY ~i~i~i~i~i~i~i~~a~~~~1~J d~l rcadh~l le ct Dr 1~4 vithin the s~~~~~;?~~Psleh- i~B~i~iithia 1 I)tcieJ. The process can be '~i~C~i~·~~'~"-~'i~if~ecP~ L i applied or identified at ~+ht~i~:~?~e~~~~l~h~jl~g II II 1~ a+ dl 3~l~j~er~b~y~j tC E~oi~, P 8~th~tk~!~o~ Thc situltiDn Lj~i~i~ ~c~ rherl roae trails can PPIJ he assessed fOllOPi~ ~~i~t~i~ 1Pdtl t)C6e e8cmtllcrr, the t~'U4 t~KS~i~l4 for ilProverents in I(enetically based product le~~~~ ~orl IE~a~j~:~·ui~i~pFn~:!~iE b? ~JOW·I ~u*Y, g 11 ip~t~Man~-t~t~t~C~:~i~l"c~d~a'i~'i~~i·~i~i~;a~;r;~~~ thc 'O BATCo document for legal Services : Health Canada 21 May 1999 _·· ___ -7- ~E~i~f~.P~P!"' deYel3~t~t ~3 eo~patabilrlg·~'b~hitcPl~uietics 'and;rurrenravail2bnlrp~fnl.P~~u~f~els4 ~:. ~· .,;~Ttff~,~aSI·~r~~':.:.· i. ..`·,· Fn·.; ~itb'that-i vish to introduce in a ~iven~varicS~ The major restriction for the use and application of plant breeding in all crops is tg~i~·a~a~8rh"~-~i~;~s~:~ bEb~';;; ._... ~~~~~ule develqq~c;n~i~ release pt qj p~~~mFrcial eulti3i: io~ob~a~tbir YOlild ~a~e in the ordp~f!:i j~ Ih·iD I~en136R Iny 50r18;c( ohly tin? IhJ 4P~LL ~6rvf3 C)PDhr Ir~C~ No'i SL)R~RIS(~ C~Y· · The ~k~j~i~j~e~t~l~ for tobacco improvclent has beec fPI The deuelopmlat al~l~:~;~~t, doe in pert i~~ Peeds~S thel~rm~dindwtry and to the most practical use ef thi~ technology. ~E lyU~i. P~N3klLEDCi r~ IIVDRI~ C~bNi53 Fb~ ~ There are ~m~j~b~F~:~"~:ae~;c~ji~e~throughaut the vaild that ~,Y'~s~e~g~e~aP~:~t~'~ imptovraent BATCo document for Legal Services : Health Canada 21 May 1999 -8- o~ notable ~hl~t~~~ir, QL 81$ ~·L ~1~!( Zimblhvr, The contribution of the in ~p~l~i~ '~·rg~ ~6~ic~ bl dr iyaaat 1~·1II1~ *Lro, ~( beca pltlt·l~~ 1~~~~~~O~S~blCi~';l~;~~a~m~Bh kfr~d~ Cb4LT , ne ~S~ "f aal~i~i~i~l Idd ~qrla Br dr naml outlined have been to ~iE~d th( ·~I ·)a~ LLI L hnl pf ~N~~ P~kda$ jf~ll:l~ld ·P*~~~ B adlitipn the!e P(~ L I ~ r ~~, ~r I U Mi~i~j~a~i~ ~~~, ~a hhml~l r3~6 ii $·r~at teldl to phqar~~g I the intrplnctipn of PE~~~P?CO ~!~~~IIItidlI11 thOlC serving thl fnlacstl of e specific end-user), BATCo document for legal Services : Health Canada 21 May 1999 -9- uu IhCLLi~j~··~; ~~S:f"T·eb~.~r6~ii~l~i~.i1~3 1 rcs4~Sor lilal illOlllt IkOV S~~ . ~ There wodd ~~pctr tp be 1 need in the develollent ~f future tobecco bretdin~ glPrr~es, ii tde r~ Iflt~rc~j lroduct hln~ae~ is to bc lchievea t~ro~h ppcl~ C conS ~r:m lnd nnh~a i bl dtvlloplenf of I· ~d·n ~f~2if~ d I ei~L~i flf~:~ ~rl~' rrul-;:: 'u~Clt'm*Fv~ 2) i ~relt'ntt~ ' I~titf bns " i.G "F k'Dt CRbS~ BATCo document for legal Services : Health Canada 21 May 1999 -10- i) ~c~j~tL: pr~itnlly It tie rca4~t~ :~~· ·--·-- ·1 ~r~tad"il;t tl~~Ylld~ ·Idi~~s ~~ACC~ - 1B~ ~I k· ·d · ·~·~dl · ~Lra in PiDnerrins the Imlo)lclt or Ilat h1Pttehnololils in licldr a~g~iMi~n!J ~f~c~t~ fhert i ~i~ii~~ 8 dneuKntinl its sc Is 1 adel Illat in the dereloplent of slethodclodies nod processes (1). ;o BATCo document for Legal Services : Health Canada 21 May 1994 -11· Ik $(~~INC ~OST ~7~ rr~irlc~PYld~ ~ L~S R . ~ . · , The g~egi~m~uhy tobacco has devdoped as a ~todtl plaor is ttlased 3~ii~b~8~aonl as s~le cc~l, as pjFjtopla;t~and inj~ther cplthie (1), TB~?'ct~;~'~h~rop~st~es~' of tapidlptcpaBatf4bl at~:to 'fatn.ce~uiar aod ;-"'·'*:.." :. ·. · '..:.~~l·Y·~~l·. a~;~i~b~E m~ the~So;"~i~i~~m~iff~P kP suu, I, i; LM,g~ ;, ~dck~ CT ~4 Cc3tli~~L~~~ Tho Sf5a with vhiih tolacco can b~B~g~i~lo form ~3Bhjidra~ti~n~n~a~y~~ (B~V~P~c~i~c~~; sieatly iae~t~~ F -- ~:~'~"""~i;t~bdi~ (2), ~i-blS~M k*CI Ca~n~cd k* hg ~Al C~ $ I~C· ~b~URb~ b~olru~~a~cy.. ~u RQRIS I ~ c~~~ FJo Cb~~t~lilC~ P(LI S A~, ~ .. it may be of con~iierable Sh~i~B) to hear thar a~ti~ioo tbal has been lir~r mo attlPpr~ N· Cn BATCo document far Legal Services : Health Canada 21 May 1999 __ -12- pasc ~FLI~LI kB~A~d~;~r~·i~;~a~'~te~' ~q m(~~~lG~i~s~L ~e repcrted use d ~Lta Lrhd plants in d~ji~;nt;~i~PI~T~n· I ~.19ilc·d ~, ·(~$ y~ li2~u IPd ~'lcletrnafcr!(5) ~1 vare achieved ieitieiiy II11 pee II~ did LLe ePqaics ~B Yti, Ihcle imolltionr ji~t~e cpaercill~ sb~~~ol ir~ njor Irollcl Icr tobaeco or ildtcd ~bcre~.i~jljei~j~`~;~$~ B~b~l Y. it 1" Lt ~~~i~:I·a processes, I~j~;h~re Pot bcln ~~=~~~7~: ··· ~t~iiEl;rolllut~t~to~a~s~E:~f~i?i I~·~*n~n_~~~?~ZI~!.~?~Ia?~~' · I r ·~~ e~il~B ~~f~p~i~t~c, of eo~nb thlt thL lort is Ltlnl Ir~resrel in I~c~i~l~i~i~~~pli~ii Llcee r- -- ,N BATCo document for legal Services : Health Canada 21 May 1999 I _ -13- ~wr ~ r~ g,,~ TC7~JIQ~ ~ CA.II r~y bt I~l~f;dF~PTfCib ~ n·t u~'~P~ii·~l~~c~r~aY~;~ 1, Plrt Ircldhl i-~c"r W I~urO,,, nl ~LF~~~~s?~l~?~~ a t~ ac~llopat ~ na e~tirlrl ri~ ncr ttf~larira, The ~q l~d ~iSj~·lti~;:ed6itt~~i~~~o·lil ·I~~tr~~ tob~cco blends (fillhr rd fln~r ~r~dcs) ~d probct (a~ity, ~rlrae c~tare Jlr~~ 1~ BMCo document f6r legal Senlces : Heanh Canada 2~ Yay ~999 -18- ~i~l the technique vherebg epical or lateral bud or even other plant sVuotnres can be ~l'i~j~d~nd aseptically grown on a c~·t·~-~j has ~ii~sidqra~!e:~fE~ll~~L id so'l~f ~jff~`~irii~i~d:'fldrieitut~5~~IEs pr~arl bendies are: (i] ~'o~"~~~~ation'of"t~;a~j~~ patticularly applicable for the Y ied I?:I ve Z~i t is it~'"~ maintendnce of plant : (urualy identifjea flDB a `plant population). to `a Bit it f ·\ \\ has been applied e,g, rorer:b~~aPental "s p~p~F~btltdJlb. BATCo document for Legal Services : Health Canada 21 May 1999 -15- (iO The Pf&FF~Pt~ Lldi~,S~t~P~ lli' fO" Of 2' g'OP~4" i' for the eradication of p~s4s, Whhfc ~pic~It' ~yt~e~~.l. Lcat) and ed~lred ·j'~id~ ~~at ~iiQgrcJ~ in t4 plant cia bceP qllird to plant tRc~ ip thc ed~ of ~I~Ldicl~o~-~t~f~_~S·' coec~z~~ ~ U ~ , ~al uc aladP$ (a~Ei~E~i;S~ Idn vhicb Ih ~eLaoo las ~ii~ii~i~' b~P!~g. II tit f~lere indlvidnal ~F~gl tissul c~tre ~oplldPr Ile~t~ cirelustlocc where tissue culture PrDPseatios ~ lati~ll is where this lubsequently ~i~i)~kitio~ rqctltbe:~~ BAfCo document for legal Services : Health Canada 21 Yay 1999 ~_ ··· _ -16- a·r F~R 'iaa~kceo ~~E~h~8~,ab~t~i~~ di~du~~ the g~~h~:ti'do::~f:t~baced · need or cost basis. Boxever, ii has~j~i~the i~ A RC~~Lep~ ~b.t~~~~ ~o~ffy~eg~ganreuch .too~ that could provide the baris of an ~t~h"a~i~ for p~pl~i~F~c;j~ai~"k~i~' ~b~d~~~ie~ a) ~f~P~T~ Md~f~~t'pr.~ei~Y~_~_pgliol regional comparisons and on the development of cultural practices for product improvement, b) W866t6~;1~-s'o~6~i~TE~3~cf~~ i~i~l cloned sePetic stability across a plant population would provide an ucellent basis for studying and optimising harvesting and curing processing practices, Ip 'O i", BATCo document for Legal Services : Health Canada 21 May 1999 -17· dC Lditc~ ·Ildr ~b~· ·Lr· I~hlL d) ~EEFJ:~:dif flrr~.j~d~ii~ilin~lt· c~tlli~~cd i~~ pnetica~, 07~·~ ----~ M ~L LI~~ ~ ~k ~~~~ ~i~, InUdi~ t~ yrtrt ~C ~~r ·~5 dac ~~n tcchiqa~s eoPld be ~tilited to~i~i~~I~~c- Ihil ~FbPdOl~ C~ IDd bPI (CCI ISCd ·dcr a Iccnar~or: (i) to rbort-eirelit the ~eetiol md ~pintare cf pllatJ fret 1 sclic~ltiq po~~tiol th~t Cre rclSlce for hlbrid yllt I#d prodPetion prior to atcplfve kb~g MQL~.. ~. (ii) PII Of ~ ~tt lil tillW f~Prl riltllfC iI tie prod~ctipn If t~o~ijol~~l~ IP~cl ~lbtid seed Iro~ctioa. ~Co doclapnt LI Ilad Slntes : Hl~t~ 4116121 Yly 1191 __ -ls- b. ~bi~ld~pgrible $olication.~f~j~i~ Anther culture (or haploid plant production) methodolokl relies on excision and ptbpagatLn of ~P~h~E~iep~Dd~f~ that have vndergonl~i4iin rhl~C~j~bG~ Th( regenerated di~Ioid (2n) plants can under certain circumstances be produced fro~~i~B~c~E~Yb)· Were this can be indaced, ~1~84~p~ti~h~6P~ (airtn ~der:ed to as ~b~j C~-~,,. .,,, a, ,~~, APPu cA·jlbcliS dF Prclr~ Cu~~ Rt`.. · (i) identification and selection of hapl~id plants Pith 'desirable characteristics' that can be chromosome doubled oV·3L~~C I to praduel hamayeous tin-bred) plants for breedins putpalls \~LLG(~L or direct we~ I~ BATCo document for legal Services : Health Canada 21 May 1999 -19· (ji) for use in the development of breeding lines for hybrid plant prPdrction, Plants produced in this manner should in theory exhibit greater heterPsis (vigour) because ~ploid derived in-breds are truly homozygous whereas those produced by conventional breeding Ire not. This is proba5ly not highly relevant to tobacco, a plant that shaus limited hybrid vigour, suggested to be because commercial tobacco cultivars ate derived fret a naturally occutring hybrid (that gives rise to an qhidiploid plant), (iii) as atool for chrolosolpal additions and substitutions, (l~i ~irOo wba~ u*l· wu;Rw~sli. ~~ Whet~~i~oas :phenotypic:JelrtionTflt~P~n~'be~b~~~n~b~e~ifl~T~d~Eo the ~EI=T=~~~f=S~Flt~#~i:~ ~-F~l~i~::- :.*-"~Y'" ~i~rimental Plaots~derTvld'iEf't~is Ipi~nd,et , a~-~e~a~u~g~,~~ pressure can be applied such as ~~el~stre~Salt af"trie~l BATCo document for legal Services : Health Canada 21 May 1999 -20· or disease resistance ~~-u~ relevance, The ·r*.mJ opportunity for identifyin~,plants nith cdpwnstre`~i~'Qattributes however ~LU ~aco.~~D~f~I~vhla eonridlrinl individlll plant cbalyei. c) Cellular Technd6nies ~Z~M~U? CPliiC P~Yr~:Y ~~ ~ The major research effort in this area again using tobacco simply as a iodol plml bat blpn dirctld ~~l~iE~ia~ti~ tir~h ~p4ul~ti~ plrtida~ly ~i~.d~ ~iith so~reses;iCb~Tc· 7ffo'i~foc~ii~e216n;'fh~eTi~°n~h~fi~i~' cn~ g~o~mte fr~p~pts.9~,9,10). In addition, effort has been focused on utilizing the spontaneous or induced variability that can be achieved in illtain circlartaaeer cf I1ePt cell culture, sa~B~q ~E~i~PCC· Q o O W BATCo document for Legal Services : Health Canada 21 May 1999 __ ·21- There ire essentillly tva types of somatic v~ri2nce: (i) S~o~dl~lcacrltian of saaltie rarilt~l ~gg~ghliiI~ liader certaia conditioos of ~l~nt C~tOlel the ucised, otpanised tissue beeDoes ~C~ ~l~c~PRa~l dl~e edl edhn. ~I fon, cnr ire a4~~1L I:5qeF~Frc_t~ycq~tl~p~le cdlh in net tl leeds te 1 ~~iPd~o!~:~I~a~)F~q,~.~'?rllq~ the ~qlae~d vhicb cpn very wf th oulcure eonditian~ ( 1 1,12,13) ~ The ~per~entor will sllcet cultare eondi~ions ~~~e~b~'5yc~~ic?iga~d ~~~lr ~lr!~lold~ge ~Jt ~~p"~w~·~;i~:~i~bv"e1~:~;~J ~4;e1~ Tlc~gXee~q~tir q·tn·l verietion or ~rl61~ d~ a~ t~ tltiltiol ~hak~ ctr; n- LnnuLc~i)-h~m);Cti~l~~~ ~~ ~li~c4~:t~l~ECgi~rptrlt II the cite of~~ itr BATCo document for Legal Senlcet : Health Canada 21 May 1999 -22- (ii)l~or indeed vbddiilitY In essence this is analogous to the above except that the variability is induced pr enhanced by the use of chemical mutagens. This approach ~F~p~p~::~i~.~~~c~i::"~~~;-kq~Q ~iFi~p and ~ei~B~i~i~i~8~?9f~~di~.t~i~ 4t~o~p';;F~6l.~a·er··~amb~lfe~t~jrR;i~ rCO~mYL;na~nmt~~nl.. nu~L~3*-(Tr I~'i'l PL~PLI~~ AhOY The follouing conclusions can be made regarding thet~Pr~t~ and of the u~P.o~i~:·i~t~a~t~cbnolopies . ~lc· - · SC~I~CiX3 Il~liRLR~~lk? i) ~OYelepme~nV .spual .4~riF~J ii) its pajcr benefit is that it can lotentially provide~~anetii~ $iabili~jr~:o~f~o~jp~'since re(enention pctenti4has been aPTd~ ~ 0· BATCo document for legal Senrices : Health Canada 21 May 1999 -23· iii) tle~4Zz~c111~52 is to I~~etet~P~ 4dut ~~ ed~~~l~ lipif!p~~~retalr ell bC ilcPt~itd Omn~l! this al)rolel LII rslevonco ~DlsPi~4PE~ where J~ti~:EritBil ean he applied directly to the clltre ad~Lr ad as ~41 I~n~·d nnsa rl j~p~i~ 'G~flil~gi·d rcsirtrcc.) ~1 f~gis' ~~iduqcd milbili~~fl ~~~~!f?~ Icncratfon to Icnerat~on ki$~ ,, a~*~ ~,L ~ r~t~r~!~l tL ceiiolv Ilrddlredi~~!~t!~loc tD be Itratellies idmliilcl for I~!~ppf~~~hr~di~!~':d~fPel'~~ is ir~lo t~c~ ~i~aai~i~i~;Ii~l~ BATCo document for legal Services : Heath Canada 21 May 1999 -2h- ~(~I~P~~~- S~nr~L~~~ In practicl,gfi~Q~me lithcuph capable of ere~tin~8 new va:iltionr in the plant is ~pited~rurentl~,bp~~h~8~ceian Ic~!teri:; plant imprPvemeab port Bcving it ~af and:lfmal pr~a~i~j~g would ne~f~i~e~;;~a~.~a~bly~lii~.h:plaqt :populdtidnsjfrom which improvements CcAehcPQa~c·r would have to be Eelec:ed,l Favine··been cured, ased·lpd processed to 1 ~i~p~iattelF IUPN C~ koa; P~tt~i; NPRwl-~I~ J· ~l~n#ic~ai~j~ ,. ~P lu;b To PN) ~ iic~~.iid;-- 4~T cc~S~a~ r In broad terms, ~T~~;K';fi~;r;8rjl~;i~~is tXe procese whereby 'i4~!efY~Ljs~4~6~EaP be.,identificdfin7lat~lre and f~netP~PJ~s~a~ P'"'"'~~'·~y~e~:·,:· ~·~~-::~*::·i~S~Edrs~~iL·-·· 1 ~8~i~ii~ tarallr.'~ip;ijrt6Ptcplants~'f or'wh~_~jr~:de~fi"nea~ii~'d:ii~s"a~'d This pneess usually follous the outlined s~a~J~ BATCo document for Legal Services : Health Canada 21 May 1999 _ ___ ___ __ -25- ~~5 ~5 ~K ~V~~·~~·SCt~~~ 1 ···'~14· 01 je~i~l~EMi~~~ d**~~nd·i 1 t~i~i~i~i~Jltr lellr ~LL~L rD Ira i %G·ul Y L~ P~c(' W*U! IkLP'i~t. ~.. I) i~e~l~j;f~k~ii~n3iliI~j~i~i~u~i kU"L~ ~~~tq,, Q F~d~i~y~?p~io·l rd~e~c~~the rcdpiaP plr~. This will include ~nm~r' d *p*dfr ~Cp~, in~P~Bf and ~E~9h Iq~~ II order art tbe aE6Y qndn and is e3~i~E~fifi~' Vr~jjZ ~ r~kt~ ~ (iii) tbr ~f~bi~iP~t~t +'~ 5"~ This csn necessitate the dcvelop~e~t and use of Ipproprilte a~i~fii~Ei~';h?~'P~~ti~rd~l ~nt ·~7 BATCe document for Legal Senices : Health Canada 21 May 1899 ·_ -26- L~~C~7~4~E ., .A (iv) Y1~5~k~B~ Pccdl to bc·~I1~X~t~o~~lt~ i -· ' s ~~· 0'~ · 15 Ct i~~NI 1L ~ci;l~)iPL~ L ~is ee~~f~t~itolr~ in hc~Bl~q Sbn lefif ·b Tll~ltPIi ICbej scoh 11 lilbt sroritive trilltp which u?~·., lead to direct expression of the Ieoc ip the Iclf. This is m FGhhp of O~C"RCY ~P~CI~L 11 i~r err inB ElpLbDi~ Of ~~Jt~i~.l~eCiifC .~gji~. Id~tYI bB~ep~ldi~~lcrll Irrca~~~p~ ~t Il~iOlOliC~ c~ocel!lc~i~il~aficr~~l;l ~tho~h IL ii ~i~~c~~B d dr futurr t~ rallg ~h t]ut B~!pd~ lelq hdt unipulatianr p IrliS Ma t~l2~iii~iG ~trfJl~s illllediatt aJefll Ipplicltion, BATCo document SI legal 8en[eeg : Heath Canada 21 May 1949 __ ·27- : T6~C~ju~c"egi;j~i~fl these molecular techniques ~epeb_ds on incleasipg the. ~Fif~Sii~h-~p~oi inECltiq lenLE~ift~F~t~L~ anO ~bBie:t~n fsiiiic~j ia~fi~ ~I~FttiV(~ Tbe ~p~9!f~( the nbitclll~ bil~e~t ii;a be able to i~k~ete seaeg' in a ~ly spe~fic'~~nne~b ThtPte~i~p~of the situation is that there has been a tS~~j~~o~theXT ge~ef~i~B~n~ caFabilites of the molecular biologist to a~j~t~f~our uP'BP~p~andi~ ois~is~Pe.p~ysfP1Dsica~j~ocha~ic~g and molecular processes thliE~~l~a~:rcgul~tfpl mddev~Iii~m~ This is part~l~ola~l:jlo~ ~j~f~p'~g and the~:is ~hreent:~;~n~f·~6~i3~ boug~j~:~~;~aste prPcerrcr 'ihll~dcc.c~~i~cially ~anifieadi~p~in~ ~b~J~b such as ba~ plant and~fbf.pPalitie~, sSpke'~il~fZ~Pt ~~:cptlnrPsatioN'~a~'·tbj;iis~:e~t~ii~B~ge 'to caincei·delir~t ct~neet~·lirrhe 'tobaCdb plaiili~ similar approach has been referred t9 at t, -······ inlernadorwl tobacco conference (Is)). ~haic pae~~~en~ineerjnsr a BATCo document for Legal Services : Health Canada 21 May 1999 -28- methodologies have been used to achie~ g~Xp~fip resistance and to p~pa~ce Il~tRC~e:Of p~'B~i? Neither of there achicvaents needed a fund;llpatal understaPding of p~'~nt ~etaboF~!_F~!_F~!_F~!_F~!_F~~~t? rather are relatively s~mp~e sir~le sen~Etrats identifiednbactcrj~ ~f systems that were vell'.studied anb~a~e;-~bi~~8 ~;p~ invertisation 1 1 loa~yiii. Iha gbill~ ~mbiii~significant I~nldliiil~ia~i~;taii~?mr nur*a~liivjv'' ~j~it~l Hou~g~c: thS'i~e~'~i~~~rci~irincc~-~-~E L~F~I~m pat~n~ib~o I~h ia..l lan''U~Pr3II (Illtl, pf~dt~-~iLld Uld Plbn~ attrihlltea tbat will p~"~;~~~v~;;od;;~t"ec~J and i~il~cilitiC ~e~fa~' set"~ar ~i~ar~ii~.~;"f~~i:·t~;;d~st-~·~,s: ·P BAfCo document for legal Services : Health Canada 21 May 1999 -29- ii) MrniPulation of the.nitrate reduct~sc,caaP_l~s (ii) M4difiedti6n of tar oicotiaertatias ~bv generic 4olineeti~8 (iii) no~b;fkation of taste and flavour snbhetie·Pathpavs (iv) ~d~Rl~iii ia~ses~.wirullural inPutri ~v: 7H;ux ?vlu~kl- ~jk~~u~L\. I*i~uF had a.bettci;:~n~d'i~-~.~ig of~Lfs~T~3~ ~i~;1T·di~PB~el t~fera?c~~~pjnrsc_t :refistdoti' in-pl~.~nd th .up~lli~lf~'atili;;;t~p~' 1Ilra~fifeiii~s ·ana fer til isi'~-iii~!·li~lrd'devd op ~tq!es _fdi. thiiir pore j c-·~ ·- ePiic~c;;~iti;-~aon,1 In otdcr-to~f~i~;~'B~*'~~i~tt and develop the approptiate technologies i~i~il"b~ liii~essaip fbr:thcIddustry td';~i~ijt~d~in;'its' co~;ercial sdi113?34~'~be"fiit~~ BATCo document for Legal Services : Health canada 21 May 1999 -30 - i. LlcePllr lielolP:ane ~i~ tcehli*cl h IL1 ~~ h~ ~ EF It FclZic~ ~ ~ IMPU~~ H~ TEt~lavi, yiT b at U~ ~QRCcO ~~ ~k~p~d~E (M Pg~r~ ~ 1Y! Int L· kcl 1~1 ~ol!priL Lleti~F~ipC~l~bie~-bil~c~tl Icle of ~cb~~rr rcnif~' f~d~t~ -5lcdor rn~~ thrt Ire f~· c ~Lfiid~cdniS~fd 9~el~l; nc~i~i~k~rtlri'n7 ~ de ·L '1 n~l~lir~c~di tba ~ be PYTtqtLtr~:tl~ ~g pd~ ~L h a~i~d· db?iib~ii~jiieiir~i:~a~h~dEl~iivt~ ~16:tO ~ Ur~ Oi fl~jiil~tl ·$~'fD;~ Indi!!U~q I Ilrics of El bed~C1Dpeg tl cl~I~q: Blh··ai·lk p·1~P L~ll~iolf~i~j~l~d· b'~ ~~ dB~~d~' h~L;f~~BCSleSI~ o~iiIr?;~li~~ll alsa~7li~~~i~~i~ii&iIrlpirc~ b p8tlcae~e fdadior~·l ollcnll~b~~ C BATCo doeument for legal Sanieea : Hea~h Csnadl 21 Yay ~999 C _ ·31- Such an approach ~i~l provide the basislfor: I) dl~tib~a~bi'ffji~ in mo9calar'renr~rovidine a baris [or trait enhaneenent b) facilitatL the~bfiatio6 d~:~:~:~:~:~:~:~:~:~:~:~:~tq specifiw~2iv73s h 6·-'·:''" - ··:PCT..:9 C] n~d~the introduction of traits inta.tbmme~ai` 'cultivdr~ $his~b~cirii~i~l'~iIn?j typa a~ii~e~ovel~ cPnbinatimr e) begin to provide focus for specific genetic engineering where more pragmatic approaches fail. i) of pr~fy. hport?~j d~T~i a Ihortminp·.bf~!dht'b;~·SEa'e.S in ipproving asrondmic or product based traits, O BATCo document for Legal Services : Health Canada 21 May 1999 -32- It is r~tCi~~L asl ,IChb~rYr;d~??~i ~~~trl~llt~Wla~PIPPF ~~~cc~~r·~~a ~cbnibcr Lthdt biCIJ~a Iql~nri~~~e biri li~i~th 6fir Ylph0liC Pd daos3treee I~Q. 5. ~b~~o~I~~al~'~lLn~rKiiri~i~~ for Ilnt sr~ Lb- fid~ Ihere bls been inerclrial pl~e-tb~ iril of soil licrl-or~d!~ 6~.~;~ rYpll· ~ell Irillt~ta the uptake af r~ap aud .h·· 'I'~' Yf~'itlcl~ Ihare I~or cs~cl ~~II )Il~~~lrt a~Ile stcr af Irinlrl ieterest ire bf t)t~Fjt~c~j~ Pf P)iC1 there ire audLnl ~:P·l eCta- Iii a~Lidi~ BATCo document for legal Services : Health Canada 21 May 1999 -33- It appeats that ep~Py~iz~pre of p~t~4~Pe"eiit to fa~j~stgps uhilst ~_~y~prrhj~~rtcn~t4~e~b~l4Ekred:~i~h a vide:variety $ "a~6~h~""'·~m42~;F~"lYd~' I~oa~Llil· AI~F:if Lv proved pollible.e~enltar~~F~nycor!~j:a in.~it:o sing continuous culture conditions it hap·not~een~nct $en po~Sible to b~k ~4~F~:~Y~ production rgrtas f~rK~ mycorrhiza rove been developed utiii2illp ti0?f~-~slr~t~in~b~n~;~e~~oviro~e?ts. "~'i"l for use of this system for cdihiefCial"beaefit depepdslp:: i) bd~c~ nterial cPrtl ii) ~a~jfi~~fii~ii~;i~~'P~f~F~;l~stor specifi~plant: types ~ I~J m'r3~1*i;a, R~ iii) eb5t"Savinps 'bnlreifueed 'fe;~t~:~Il'fser use" BATCo document for Legal Services : Health Canada 21 May 1999 -36- The use,of::~p~&zaiSiirn;;t been cop~Ei~lly va~idate'~ ~esv-, To date, the fulr benefits of using such symbiotic soil micro-organisms ",,,l :a ~I lour NIIYIUI iYI YOUII ~1IYj. m~loaatl~ under defined conditions and might provide a basis for engineering additional beneficial changes in the organisms for mutual benefit~ ConcludinR Remarks The future is technically challenging, but the emerging technologies can and should be utilized to develop novel tobacco breeding strategies, designed to wet, the future needs of the Industry. There will be 1 need for the Industry to carefully define its goals and to maintain a commitment to fundamental research effort to achieve substantive improvements in tobacco~ aAr ""b"" 'C" ,~ ~b~1-L1~J~ ~· O1Hnl~, \*Vc~t~NLhLL uc hxrq m ih WL hr~UO-r~jli~Cy~ ~ i~pu IC rM , O BATCo document for Legal Services : Health Canada 21 May 1999 ·· References: 1, Nicotiana, Procedures for Experimental Use. USOA Technical Bulletin Bo, 1586. 2, J. Schell et al, Plant Cell Transformations and Genetic F~gincerins in Plant Improvement and Somatic Cell Genetics. Ed, Vssil Academic Press. (1982) 3, Watanabe, Y, (1975) Jap, J. of Breeding 25 (1) 79. 6. Blakeslee, A.F., Belling, J. (1924) J, Hered, 15, 195. 7. Chih-chinp Chu, Haploids in Plant Improvemefi, in Plant Improvement and Somatic Cell Genetics, Ed. Yasil Academic Press (1982). 8. ~elehess, G,, and labib, C. (1974) lolec~ Gen, Genet. 135, 2ii. 9. k'hite, D.a.R,, and Yasil, I, (1979), Theor, Zlppl, Genet. 54, 239. 10, Cocking, E.C., George, 0., price-Jones, n.J., and Paver, J,B. (1977) Plant Scil bett, 10, 7. 11. Sacristan, M.D., and Helehers, G, (1969). IPlec, pen. Genet. 105, 317, 12. Larkin, D.J., and Scovcroft, W.R. (1981). Theor. Appl, Genet. 60, 197, 13~ Burt, l.G., and Hatzinger, D.F~ (1976), J, Hered. 67, 181. 14. Bidholm, J.M. (1977), In 'Plant Tissue Culture and its Biological Applications' Ed. Barz. Sprineer, Berlin. 15, Scowcroft, W,R. (197'71, Adv. Agronomy 29,39. 16. Thomas, E., King, P,J., and Potrykus, I,(19j9). Z. PfiaPzea, Zechtp, 82,1. 17, Proceedings of 'CORESTA' conference, Greece (Sept. '85). 18, Second International Tobacco Exhibition, Richmond Virginia (1986). 0· BATC6 document for Legal Services : Health Canada 21 May 1999 ONOON ~RCH 1988 SMOKING ISSUES CONFEIIMCE · i Al HEARD IN RESPONSE;O RICO~MENOATIOKS GROUP R&O 4CTIIIIIES I OF REGULATORY BODIES Introduction In nir opening remarks the Chairman has laid that bath BR;, frop its Research activities, and independent researchers have da:l that chaliengei, or ean be used to refute, rimpie conclusions being drawn by there bodies for whom p3rely scientific argument seems of n~inor importance. hch of this data war gathered in response to Regulators, 1 shall give examples where this shows erroneois judgements are made. BATCo document for legal Services : Health Canada 21 May 1999 The other response, which I shall address, Is quite different. Some regulators give very clear directions for improvements in product characteristics · improvwents that they deem relevant to the S&H argument and that they would wish the Industry to pursue. This, in my view, presents an opportunity · when the regulators refuse to become involved in suggesting how they would see the product imroved and simply take the stance "rinoking is bad" we face a difiicul: scenario, I shall consider how product changes might be made in the light of overall direction from the regulators, ~titudes and Recommendations Of Regulators Who are the Regulatory Bodies? Difficult to give a good definition but it includes those authorities, official or unofficial, that advise Government, lead to legislation or influence public opinion and hence our consumer. BATCo document for Legal Services : Health Canada 21 May 1999 __· X ble shall examine the attitudes that have developed and the recomneadations made by these bodies, The iollawing slide 1 lists a nu~er of recent reoorti rrwn Regulatory Bodies, In tems of the arrociation between active smoking and disease the Ruthritier accept the 'Ilurality theory'. little new has emerged in these reports, although some apti-s;r~king orgabiratibnr are carrying out or funding research in;o mechanisms of diseases such as lung cancer, The American Health Foundation, for instance has a subs.antial programme of research into tobacco specific nittoswines, including their possible role in altering genetic material, Under the aus~iler of Grout eBO we fund basic research Into aechar~isas of rmokiog·associated diseases at several reputable medical de~arinentsiins:itutes since this rereare8 may resolve the ~ssoci ati onlcausal i tY controversy ~ ,,I~, BATCo document for Legal Services : Health Canada 21 May 1999 The major theme, however, of the reports from Regulatory Bodies is related to Environmental Tobacco Smoice; in some it is the only thee, i, Environmental Tobacco Smoke Recent years have seen a marked escalation 61 the Paaive Snaking problem, with extensive coverage in both popular and scientific publications, The anti-smoking lobby seems to have switched its attention almost totally to this subject, trading on the emotive isrlres of the effect of smokers on the non·smoker, The reports from Regulatory bodies in this area have drawn various conclusions about possible associations between ETS and diseases, no~ithstanding the frailty of epidemiological techniques in this area, Two of the more unbalanced statements to have emerged from the most distinguished of BATCo document for legal Services : Health Canada 21 May 1999 such authorities are shown in the next Slide 2, It is important that you are all, aware of some of the misapprehensions surrounding ETS since these are proving a source of erroneous conclusions by those pressurising to restrict smokers' freedom, In many studies on ETS, there is, for instance, no knonledpe of dose whatsoever beyond notina that individuals are married to smokers. In other studies based an often specious information, the exposure of non·rmakerr to smoke atmospheres is translated into extraordinary claims of lequivaient cigarettes smoked', An important source of error in many external publications stems from the assumption that ETS is the same as 55. In fact, ETS is quite different from SS: BATCo document for legal Services : Health Canada 21 May 1999 i, EtS is a dynamic mixture of substances formed as a result of tobacco smoking, ii, ETS is created from SS (80-90:) and Exhaled smoke, iii, SS and Exhaled smoke are highly diluted as they form ETS and this leads to wny changes, We have found that: i, EiS components rise and fall with time; decay rates vary for different compounds, ii, ETS levels of Particulate matter are dnly 50·502 those predicted from SS yields, BATCo document for Legal Services : Health Canada 21 May 1999 ETS nicotine is only 40·501 that predicted from SS levels · and decay rate is faster than for an? other component. iv, ETS nicotine is mainly in the vapour phase - in SS nicotine is mainly in the Particulate phase, dil this data goes to show how conclusions formed on SS information can Se wrong. Here are two examples of PLiblications that confused ETS and SS: i. SS nitrosamines are 100 X corresponding values for MS. Hoffman has speculated that passive smokers are more at risk from nitrosamines than active smokers i! ,,II I BATCo document for Legal Services : Health Canada 21 May 1999 ii, Mohtashamipur et al, have submitted a paper ~or publication that compares biological activity of condensate from MS and SS, They find SS to be slightly more active and conclude ~~. greater biological risk caurd by paslive IRlaking than by MS smoking III E:S is widely portrayed as a major pollutant in domestic, working and social situations. This has been refuted by Grey who has studied the 'rick building syndrome' and shown that EiS is a minor factor, lie also are gathering data to help set ETS in context: i. Background levels or CO and NO vary over 24 hr, due to ttaRic, industry etc, Peak background levels of CO last for 2 hr, and equate to 2 cigarettes smoked sisultaneourly in an average room, ..I·~ BATCo document for Legal Services : Health Canada 21 May 1999 ii, Surreptidous monitoring of at~os~heres from various smoking environments · living rooml tjtchen, car Indian restaurant produced a general scan showing: .IbH eoncs, of nicotine (3-3809,1a3) - nicotine was a minor eomoonent rel, to other volatile camponents (frblll cooking, polish etc.) Finally, RJR studies in US restaurants and planes show that on average people are esposed ta very low levels of ETS, equivalent to smoking (1/100th of a cigarette, Sunrmary of ETS Objectives Slide 3 summarises our objectives for Research in the important area of ETS, BA~Co document for Legal Services : Health Canada 21 May 1999 Picking up on two of these we should first note that in the context of 1 a 2 we need to find reliable markets for ETS, Clearly nicotine, though specific to tobacco is a poor marker. Our sights are nov set on specific colponents of the par:iculate n~n~atter. Secondly, and of considerable relevance to this meeting, we need to publish our findings. Publications The Tobaecl Industry has by no means been silent on the issue of passive smoking and ETS, Firstly, within the Industry RJa in particular has shared very freely its research findings but PM and BAT are also publishing wherever possible, Slid!lshows the BAT publicaticns. We shall present the keynote paoer at the forthcooling Conference an indoor Air Quality in London this year, BATCo document for Legal Services : Health Canada 21 May 1999 The TAt has produced special publications on the general and scientiRe aspects a~ EiZ. Just this month, having seen a draft of the 4th Report of 1SC, TAC called a meeting with the Minister of Health to protest the poor science and the propareC anti·noker line propaseii by those responsible for the report, The question for this Rleeting 15 · how do we gain lore impact from these important research findings than we have achieved to date ?? 2. Product Modifications Some Regulatory Bodies consider product modification policy sue:essful~ They conclude that lower delivery is responsible for reCuc~i3n in lung cancer (ignoring compensation, conveniently). BATCo document for legal Services : Health Canada 21 May 1999 _· Ticy an nou addressing further modificationl required. Of course, not all di the Regulatory Ruthoritier Ire willing to follow this course. Neither the US SurgePn General nor the Pn~e~ican Health ioundation are 7repared:o pursue a line of prodd irn3mveant, But in canada, in Germany and in UK there is grrin9 interest in rake eom?onentrl iot instance, ed we can dnticioa!e some direction ior product change emanating ~roe these enguiries, Spec:iic madiiicatioli tither started (e.l· ~SI 4:r Retort) or we can anticipate are: i. Mainrtrean · continuing tar and nic reduction. .tarlnicotine ratio re$ction Slide 5 - tar qual i tY - other nora BATCo document for Legal Services : Health Canada 21 May 1999 2, llS · less ridestream Slide 6 less irritant, obtrusive Skillfully managed, product developments based on consumer demand, itself based on statements from the Regulators, can present a positive step by the company and a conm~ercially competitive position, The success of Silk Cut in UK is a testimony to this. ihe question for us today is how aggressively should we respond to or anticipate Regulatory directives ? Evolution or Revolution So far the industry in general have pursued Evolutionary approach, certainly in terms of overall deliveries. To a larger extent the rate has been dictated by the willingness of the consumer to accept the changes, BATCo document for Legal Services : Health Canada 21 May 1999 Concern has been expressed originally by Russell, that tar Is the undesirable element of smoke and that nicotine, the prime stimulus far smoking is relatively tolerable. `Ihis suggests a line of developent in which tar is reduced but nicotine remains relatively high, Over the last 20 years, as overall deliveries in UK have reduced, the T/N ratio has fallen from 15:1 to 1111, Again, gradual evolution. In the case of tar quality · we still lack definition but as biological test methods improve, we may see 'light at the end of the tunnel', Other nora, the minor undesirable elements of smoke, bye not been consciously altered in cigarettes to date but any cigarette modification in development that push these the wrong way are abandoned, BATCo document for Legal Services : Health Canada 21 May 1999 Any reduction of sidestrea snake wirsions iron cigarettes has, apart from one or Bo initiatives, been accidental, Thus, reductions in weight of tobacco burned per cigarette (whether due to reduced leaf usage, incorporation of expanded tobacco or circumference reduction) will have contributed to any observable reduction, ~he 55 initiatives by our co~petitors were based on the principle that visible s~desbeam can be ndlced through the use of special cigaret~ papers. These have failed commercial ly, This gradual evolutionary trend in product modifications looks as though it is about either to end or at least to receive a sharp knock, It is not only from within the traditional industry that the challenges may come, 3 years ago, ATP attempted to launch a product that simply ..1., BATCo document for legal Services : Health Canada 21 May 1999 delivered nicotine vapour and Elvourants by drawing on an unlit tube containing a special plastic plug. Just recently in US, C A Blockers, a small eon~panii, has announced its plan to launch a cigarette called Optima that has reduced health risks. The 8 mg cigarette has an additive N·Bloctio that blocks the action of nitrosamines in living syste~s, The company is planning to license cigarette companies to use N-Bloctin. A truly revolutionary approach to those wno criticise todays product is by R J Reynolds. They have announced their intention to launch a smokeless cigarette. Slide I RJR Sankeless Product The basic principle of this product is shown in Slide BATCo document for Legal Services : Health Canada 21 May 1999 ·_ ·_ slide gives the background to the project dr we know it. the project has senior company jacking and aims at the Iperfect ci~arette'~ Tining cons'derationr of the new product are su~narired in Slide Slide shows the principal attributes of the Smokelesi cigarette. The type of Testing protocol that RJh are pnuing witt their product is shown in Slide Regu!atoty issues so far identified with this product are sumnariEed in Slide BATCo document for Legal Services : Health Canada 21 May 1999 BAT Resoonse Within the Group we have launched two new projects, Project Airbus in B1W has the aim of identifying a s~okeless product (but with rome targetted improvaents over the RSR product) by the final ouarter of 1988, Group funding of this project is 1500,000 for 1988, If this exploratory phase Is successful, this w(~l call for 3 very large eomnit~nent of at least S2C mn, over 4 years to cover R&O/capital cost to test market stage. This is o3r Revelutionary appmach, The second project is called Greendot, This reflects the Evolutionary approach to product development, albeit based or rapid extranolation from today's position, The BATCo document for Legal Services : Health Canada 21 May 1999 s,icipl objletive of treendPt ii shown in Slide . The consuer acceptability oi such develoClentr II "ee" as key (IljdP ).Slide shows some of Conrun~r Regui~en~entr of such a product, Group funding of this projelt parallels t~at of Ai~lili ~nd tic·scaies are expected to be very similar. Finally, to pun all three Innovatory Proludr together On one Slide ,,I,· BATCo document for Legal Services : Health Canada 21 May 1999 Suaa~l i. We have soundly·bared data that challenge lone of the conclusions drawn by the Authorities, particularly in the area of ~5, pu. Uhat further data should we he reeking and How do we gain mre inpact from its publication i 2. iie have ideas for Revolutionary and for Evolutionary Product Sevelopnnent reflecting the trends let by Regulators. pa HoW aggressively should we respond to or anticipate in wr product Research these trends i tlr~tfkf~ BATCo document for legal Services : Health Canada 21 May 1999 C 1991 FRC PROGRAMME NOVEMBER 1989 A NEW STRUCTURE FOR R&D IN THE GROUP: FUNDAMENTAL RESEARCH CENTRED ON ONE ESTABLISHMENT (FRC IN SOUTHAMPTON) OTHER GROUP R&D CENTRES TO CONCENTRATE ON APPLIED R&D~ OUTLINE R&D PROGRAMME FOR FRC pRESENTED TO THE TSRT SUBSEQUENTLY ' A NUMBER OF MEETINGS WITH R&D AND MARKETING DIRECTORSI LEADING TO REVISED PROGRAMME (AGREED TSRT NOVEMBER P 1990), o c~E, BATCo document for Legal Services : Health Canada 21 May 1999 ORIGINAL PROGRAMME ' CONSIDERABLE EMPHASIS ON: REGU1ATORYIDRTVEN PROJECTS (RESPONDING EITHER TO euRRENr oR ANTICIPATED PRESSURES) INNOVATIVE eONCEPTSI LATEST PROGRAMME 1 EMPHASIS SIGNIFICANTLY CHANCEDI PRODUCTS SUPERIOR tO COMPETITION (PARTICULAR1Y PM) IS CLEAR GROUP PRIORITY I NOW REFLECTED IN FRC PROGRAMME. BATCo document for Legal Services : Health Canada 21 May 1999 OTHER MAJOR CHANGE . PRODUCT INNOVATION8 PRIORITY ON RESEARCH FOR NICHE MARKETS RELEGATED IN ~MPORTANCEI PROJECTS AIMED AT RADICALLY DIFFERENT CIGARETTES (C~F. PREMIER) SHE1VED1 BUSINESS OBJECTIVES: i, INCREASED eOMPETITIVfTY THROUGH SMOKE QUALITY IMPROVEMENT, 21 INCREASED COMPETTTZV~TY THROUGH INNOVATIVE PRODUCTS, 3, ENABLING COMPANY TO OP E' RATE UNDER INCREASINGLY RESTRICTIVE REGULATORY PRESSURES, 4, ENABLING COMPANY TO OPERATE UNDER INCREASING ENYIRONMENTAL CONCERNSI p BATCo document for Legal Senrices : Health Canada 21 May 1999 SMOKE QUALITY (35a) 1~ CHEMOSENSORY RESEARCK BROAD OBJECTIVES: (I) TO RELATE CHEMICAL AND PHYSICAL PROPERTIES OF SMOKE (ACROSS THE FULL DELIVERY RANGE) TO SMOKING SENSATIONS AS A BASIS FOR THE DEVELOPMENT OF SUPERIOR PRODUCTSI (II) FOR LOW TARINIC RATIO pRODUCTS, fO IDENTIFY AND OVERCOME THE EXISTING BARRIERS TO SENSORY AeeEPTABILZrYI PROJECTS AGREED COVER IMPAeTIIRRITAtlONr AFTERTASTE AND 180DY" AND IWOUTHFULL"· O BATCo document for Legal Services : Health Canada 21 May 1999 2, INF1UENCEOf CIGARETTE DESIGN ON S#OKE aUA~ PM PRODUCES CIGARETTES OF 6000 PHYSICAL PROPERTIES AT LOWER PRESSURE DROP THAN BASI OBJECTIVE OF CURRENT WORK I fO INVESTIGATE RELATIONSHIP BETWEEN PHYSICAL PROPERTIES OF TOBACCO ROD AND SMOKING QUALlfYI RESEARCH INCLUDES THE EFFECT OF PARTICLE DENSITY, SIZE AND SHAPE AND OTHER PROCESS CHANGES ON PLOW RATES AND pRESSURE DROPS, ICX) BATCo document for Legal Services : Health Canada 21 May 1999 3, ToeAcco MoDIFIeATIaN HISTORICA11YI SDUTHAMPTON R&D HAS SOUGHT TOBACCO TREATMENTS THAT REDUCE THE SUBSEQUENT FORMATION Or MINOR COMPOUNDS OF INTEREST TO REGULATORS, Now BROADENED c OPPORTUNITIES SOUGHT, THROUGH SIMILAR TREATMENTS1 TO MAXIMISE THE FORMATION OF COMPOUNDS WHICH IMPROVE THE SUBJECTIVE QUALITY OF SMOKEI BAT~o document for Legal Services : Health Canada 21 May 1999 EXAMPLES OF PROJECTS BEING PURSUED INCLUDE: (f) GENERATION OF FLAVOUR PRECURSORS EtE( AMrNO AeIDSI AMMONIA AND SUGAR BY BIO·eHEMICAL PROCESSES, (TI) EFFECT OF RECONSTITUTION PROCESSES ON SMOKE QUALITYI (I~r) EFFECT OF CHEMICAL AND BIOICHEMleAL PROCESSES ON THE FORMATION OF MINOR SMOKE COMPONENTS (OTHER NOXAE), I' ,p ·O ·o BAtCo document for Legal Services : Health Canada 21 May 1999 INNOVATIVE PRODUCTS (20%) CAC COMPANIES POLICY I BUILDING B1DCKSI NOT PROTOTYPE PROI)UeTSI EREENDOT: TO CREATE LOW TARINIel RATIO PRODUCTS (MARKETINE AND REGULATORY SUPPORT)~ CONSUMER PRODUCT TRIAL (BATCol) ON FIRST SPIN-OFF - ENCOURAGINel FR To REDUCE TARINIC, RATIO FURTHER4 INCLUDES USE Or eASTEISHEEt MATERIALS, CHEMICAL TREATMENTS OF TOBACCO AND MICRO-ENCAPSULATED FLAVOUR MAtERrALSI BATCo document for Legal Services : Health Canada 21 May 1999 ULTRA-LIGHT WEIGHT STRUCTURES EFFICIENT USE OF TOBACCO TARGET MAINSTREAM AND S/OESTREAM DELIVERIES~ Eiu·rIo# BAT WORK HAS SHOWN IHAT RELEASE OF NICOTINE1 MENTHOL AND OTHER F1AYOURANTS TO SMOKE STREAM INFLUENCED BY THE NATURE OF BfNDrNG MATERfAII THIS WORK: I WILL CONTTNUEI WIL1 BE EXTENDED, TO INCLUDE STUDIES ON THE' MIGRATION OF COMPOUNDS WITHIN tHE TOBACCO ROD, WIL1 INCLUDE MATERIALS MIGRATING FROM PACKAGING MATERIA1SI BATCo document for Legal Services : Health Canada 21 May 1999 REGULATORY ISSUES (28%) i. REDUCED IGNITION POTENTIAL ONLY USA HAS REGULATIONS THAT NECESSITATE ESTABLISHING AN ACCEPTED METHOD FOR MEASURING CIGARETTE IGNITION POTENTIAL ' EXPECTED TO SPREAD TO OTHER COUNTRIESI CORESTA HAVE SET UP A TASK FORCE IN WHICH BAT HAS TAKEN A PRINCIPAL LEADI ACTIVITIES PLANNED FOR 1991 ARE: FURTHER COLLABORATIVE STUDIES AIMED AT REFINING THE EXISTING TEST METHOD I FABRIC EVALUATIONS TO ENSURE CONSISTENCY AND UNIFORMITY DF COATING, WORK ON INDIRECT METHOD WILL START IN 1991. BATCo document for Legal Services : Health Canada 21 May 1999 2, SEARCH FOR B_IOASSAYS BAT's PoiIcu oN BrOlOGICAL TESTING rS: I tO MONITOR TRENDS IN NEW BIOASSAYS; DEVELOP EXPERTISE IN THOSE WHICH MAY HAVE RELEVANCE, DESPITE UNCERTAINTY OF CURRENT IN VITRO TESTS1 THEY eAN INDICATE THAT SOME CHEMICAL CHANGE HAS OCCURRED AND FURTHER RESEARCH TS REQUIRED, THE TESTS CURRENTLY AVAILABLE WILL BE USED TO SCREEN NEW ADDITIVES OR SIGNIFICANT PROCESS CHANGES BEING EXPLORED IN R&D TO CHECK PERTURBATION FROM THE NORMI BATCo document for Legal Services : Health Canada 21 May 1999 3, ADDITIVES AND MATERIAI_S ADVICE PROVIDES SERVICE TO OPeOS,: I REVIEWING INFORMATION ON PROPOSED NEW ADDITIVES AND MATERIALS I MAKING RECOMMENDATIONS AS fO THEIR ACCEPTABILITY, ~ MAINTAINS AN AWARENESS OF CHANGES IN LEGISLATION AND REVIEWS CONFORMITY OF ADDITIONS TO SPECIFIC GUIDELINES, I MAINTAINS DATABASE ON AaoIrrvES THROUGHOUT' THE BAT GROUP, PROCEDURES FOR ASSESSMENT OF NEW/EXISTING MATERIALS WILL CONTINUE tO BE DEVELOPED IN CONJUNCTION WITH CA~ COMPANIES, e BATCo document for Legal Services : Health Canada 21 May 1999 ERVIRONMENTAL ISSUES (17%) i, ENVIRONMENTAL TOBAe co_SMaKE ETS eo~rrNuEs To BE A MAJOR ISSUE BUT FOLLOWING THE TSR~ MEETING IN NOVEMBER 1989, THE LEVEL OF IN-HOUSE RESEARCH WAS REDUCED, fHE 1991 PROGRAMME CONTINUES TO PROVIDE FUNDAMENTAL INFORMATION ON: - eHEMIeA1IPHYSICAl NATURE OF ETS I PERSONAL EXPOSURE DETERMINATIONS THROUGH NICOTINE METABOLITES I SUBJECTIVE ASPECTS Of ETS, BATCo document for Legal Services : Health Canada 21 May 1999 2. To i A L $ I b E S i R E A M..~ R_E O U e i I o N MOST LIKELY DRIVING FORCE FOR INTRODUCING SUCH PRODUCTS WILL BE ENVIRONMENTAL CONCERNI WE HAVE NO FUNDAMENTAL UNDERSTANDING OF THE MECHANISM UNDERLYING THE LOW SIDESTREAM PAPERS, BEING STUDIED fN ORDER THAT . FURTHER OPPORTUNITIES eAN BE CREATE~( SEPARATE1YI EFFORT BEING DEVOTED TO CONCEPTS FOR LOW SIDESTREAM PRODUCTS IN WHICH CIGARETTE DOES NOT BURN BETWEEN PUFFS8 BATCo document for legal Senrices : Health Canada 21 May 1999 3, FILTER MATERIALS NEW PROJECT INITIATED - PRIMARY AIM IS ~O REDUCE THE ENVIRONMENTAL PROBLEMS ASSOCIATED WTTH CIGARETTE BUT~SI THIS WILL FOCUS PRrNeIPA11Y ON THE MODIFICATION OF CELLULOSE AeETATE FILTERS TO PERMIT VARYING DEGREES OF DEGRADABILITY ONCE DISCARDED( INVESTIGATIONS INCLUDE MATERIALS MAKING UP TIPPING PAPER, GLUE, PLUG WRAP AND PLASTIC~SERI AND FT~RES, BATCo document for Legal Services : Health Canada 21 May 1999 .g ~ 40 q a~ c~S 5" ii Y g 6 H R~I i ~9 a o ·n, BATCo document for Legal Services : Health Canada 21 May 1999 E i5 B a u w~h n P I i a ~e h; v oS1 t ~m %rk% I P I · br I; I; , _u i; i; p i;); F ~6 a a ab a aI Bi r oa M gr ao BATCo doeumtnt for Legal Services : Heath Canada 21 ray 1999 SURMARY OF AFTERTASTE POSITION PAPER 1~ AFTERTASTE = AFTEREFFECtS I,E, ~NelUbES TASTES eE~ SENSATIONS (MOUTH DRYNESS1 MOUTH COATING AND RESIDUAL ROUGHNESS) AND TS DEPENDENT ON TTMEI 2, LITTLE OR NO PREVIOUS STUDIES IN TOBACCO INDUSTRY 3, PRODUCT DIFFERENCES - SHOULD BE ESTABLISHED 4, CHEMICAL CLEARANCE (SALIVATION) - CHANGES 5N SALIVA CHEMISTRY AND PRODUCTION1 OF KEY IMPORTANCE TO AFTERTASTE8 5~ DRY MOUTH - SOME EVIDENCE AGAINST A REDUCTION XN SALIVA FLOW RATES BEING RESPONSIBLE, ASTRINGENTS (PHENOLS?) IN SMOKE MAY BE MORE IMPORTANII BATCo document for Legal Services : Health Canada 21 May 1999 AREAS WORTHY OF INVESTIGATION A~ TO ESTAB1lSH IHE NATURE OF AFTERTASTE FOR A RANGE OF TOBACCO TYPES, AND WHETHER IT CHANGES WITH TIME, B~ TO IDENTIFY THE TOBACCO SMOKE DERIVED RESIDUES IN THE MOUTH AFTER SMOKING · PARTICULARLY THOSE THAT LINGER AND HAVE SENSORIC PROPERTIES, C~ TO LOOK INTO THE SUBJECT OF ASTRINGENCY OF SMOKE AND ESTABLISH ITS ROLE (IF ANY) fN THE SENSATION OF "DRY MOUTH"I BATCo document for legal Services : Health Canada 21 May 1999 SAMPLE MOUTHWASH eEeK RETENTION PEAK llOL IIE~ES IDENTITIES (MINS) 2·7 4·6 1,1·DIETHOXYEIHANE 1-PENTENE ~·PENTENE-P-ONE PYRIDINE PYRROLE TOLUENE 11·12 7 DIETHYL CARBONATE CYCLOPENTANONE 19·26 9-11 1-CYCLOPENTEN·1-ONE 2-METHYL CYCLOPENTANONE 3-METHYL CYCIOPENTANONE FURFURY1 ALCOHOL XY1ENE 2-ETHYL FURAN 32·38 13-15 P·METHYL CYC1OPENT-2-EN-1-DNE 2,5-DIMETHY1 PYRAZINE ETHYL PYRAZINE CYC1OHEXANONE PYRANONE Z,S·DIMETHYL P-CYCLOPENTENONE BATCa document for legal SerJices : Health Canada 21 May 1999 IETEITB N45L Il~fS IDENTITIES cnIns, 41·46 16·19 3·METAYL CYC1OPEMT-2·EM-1·OME YIMYL PYRIDIRE 3-nETAYL E·FIRAMOME PHENOL 3·PIO)YL CYtlOPEnTERE(1) TRIMETHYL PYRAZIRE + 2·FORRYL 5-METHY1 PYRID1E 50·52 20 CYCLOTERE O·CRESOI 2,5 DInETHYL 2-CYC1OPEHTEMOME 55-59 21-23 M·CRESOL ETHYL CYCL(HEXEHE P·CIESOI TRInETHYL 2-CYCIOPE~TE~·1·OME 65·67 26 IN0O1E OR BENZY1 CYANIOE DInE~HYL PHENOL 32-36 TRIACETIM #rCOTInE PBTHALATES BATCo document for legal senieep : Heath Canada 21 May 1999 GREENOOT PRODUCT APPLICATIONS ~BJ~E~II_VE: To PRODUCE A LOW TAR (4nG.) PRODUCT WHICH HAS IMPROVED SMOKTNG pERFORMANCE OVER CURRENT COMMERCIAL 4 MG, PRODUCTSI METHODOLOGY EMPLOYED: LOWER TARINIC, RATIO:· 7:1 (oR 5:1 EXCLUDING HUMECTANt) LOW RDD DENSITY:- APPRDX~ 200 MGICC IMPROVED "FRONT END" MECHANICS: THROUGH FILTER USED LOWER BIOLOGICAL ACTIVITY: HtlMECTANT DILUTION OF SMOKE GREATER PERCEIVED TASTE (AT GIVEN DELIVERY LEVEL) BATCo document for Legal Services : Health Canada 21 May 1999 PRODUCT PRODUCED A USE STYLE 4 MGI PRODUCT CONTAINING 70% CAsED, DIET EXPANDED TOBACCO, 6% HUMECTANT LOADING, DUAL PAPERICA FILTER 59 MM ROD/25 MM FILTER FORMAT. DELIVERY DETAILS.. PMWNF 4 MG (1,2 MG. HUMECTANT) NICOTINE 016 MG1 PUFF NO1 8 CONSUMER TESTED IN GERMANY IN PACK PLACEMENT TEST ON 160+ CONSUMERS, GAVE COMPARABLE OR SUPERIOR ACCEPTANCE RATINGS YSI All MAJOR COMMERCIAL BRANDS IN MARKET (DELIVERY RANGE OF BRANDS 6·9 MG,) TN TERMS OF TASTE, STRENGTHI MECHANICS AND OVERALL PREFERENCE, f~R~: Tb BE CONSIDERED BY TBM FaR FUTURE LINE EXTENSION PRODUCTS TN 1992193, BATCo document for Legal Services : Health Canada 21 May 1999 BET Tx~s~ies BoarbPrese~n~ion AePulatorv Authorities -~wct wm C~sa~tte ~sisn Xncreasir~ ra~ulatory Ir~zssuws will lead to charges in atr oxcent ~a~c~Pcts ard will hwe a dc~ai~mt influence ca~ f~t~ cigarette darelelm~nt, pie foll~irg wllntries (areas) are forrrmlatirg regulatcny resuirermnts: me Irde~rbent Scientific C~o~issicn m S~H ~h influerce over ~mnrtlwealth ce~ies) DxoFa Ge~sany Federal Health IrstiMe; Ger~an iced law, M: Owni~iw (D~roFe against ~d~et F~D~Jrarmo~ · ttSA Depa~u~nt of Health ard I~m~an ReKxI~s; Cer~e fc~ Tc~wa~ Prccb~ctr; (K8~edy Bill) CaMda Health ~n~ Welfare CaMda Middle ~st Sa~di Arabian Standards orgarisatiPfi ~~-·-· ·-·- --~V1 BATCo document for Legal Services : Health Canada 21 May 1999 I A srma~Ly will he giwn of the anwe d pmpmed ~t,reep~iren~nts in t~u~se irdivi~ cantries. ~ fol~irq fc~r $ics VFU be awidaredl i. Additives 2. Tar, Nio~tine, anl qengil "tcode c~colwts". 3, Firesafe Fo·e~cts 4. Sides~am ~missieo~s BATCo document for Legal Senrices : Health Canada 21 May 1999 Mdi~ives ~ ~ ~ ct leter$ls a $eraiE1~E tbnt a Fnsent in cigarettes ard tbat ~ ta ~ area ii interest irrm the tcPdcnle~cal st~si~ is s~r~a~ k SWDE i, ,~ ~n~cemms fcr aE~iirq m3terials fl i ~~ ard ~ otber ~ Ir~strie~' ~mPaZ~eS( but these are ~eirq t~t~d, Ce~srde~ce · Y ~FPwal ItL ~Ji~icierfe ta ~ le~er tetm, L, ~fo~n~ntely rl~ issles, sdentific lo3ic is ~ipse~ by public pezeeptirrs ard ve ast be ready te at a ~ ~ ~nrtWpate Feasible QitiEi~, L terms el Milnerability based · the cankal sbzrhae a i, IlmPEctants- glyeeral, F~Wlene ~ycol, s~itdl level a~f#. 1~, Prcbl·: xa b key caltici~ d glyceml zrd ~ ~ · 1 altcrwt~ves. S~lies ai~cicis~ tt~a ~rmeai~nt~ are beirq cballuqcd, i, CdSlrqJ - ~ USbgB 'I~ LiaePICOr arOa, SU~J~, ~Ja~dl prr~d~ets; mqar Mt~aal. to t~a~o~ TcPdcol data exists + these i~diti~s. 'O BATCo document fbr legal Senlees : Heath Canada 21 May 1949 3, Flavcur ~terials · ~ to 0.31 a~plicaticn, Vast array (up to 10oo )~ FeJ tave goo3, tcPdcol data, ~tany are Mt~aal; even to t~a~, hut xm3 will ~ dcubt he cfu~llerged as regulatmt F~Pte aa a~it~ve~~ ~iticsally we on eject pteble~xs if ar~ c~pnent is an i~m~trial cbemical - wc~kar wpana*e testing, Ilcetalde~ri~s is a flavaa ~e~usR nw )wa~ to be carci~o~ic: - it Kill not be ~zsed in tew BavPrrs. Beirg t~rmwd fraP e~dstin3 lorrmlatias. (. Blsldisi pgPl.diaon ard ~IVQDd~L~id pganir mJld Y ~sent a prrfil~. we are oapletin3 a register of all materials Ised in mat~aehn~e of c~ cigarettes, ~I~n ~aie~itise mrj Fn~Pblens, ~ general we mast be Feeparal to n~Ne fraD syntbetics to rare e~sive M~blmaterials, ard wtu?re pessible use tc~aa~n M~alpr~m~cts. ~' "Yd'. Ijfp ~1~L tO IL~LL ~CIA·Cl~hL Y/J~A~*~ BATCo document for Legal Sedees : Health Canada 21 May 1999 _ I· ··___ C_··· ·__ ~as~ Himtin? ard p~ml yrado ee~n~oent~l Ibere ~we ~een awes to prt EBilLt~P (n B Fnirdpll srPke ~e~s (tar d nioltire) in mael caPltries for sari years. ~itignlly, there have bean limite~ init~ati~s by r~l~trP~ to rerp3t Ca~j~QI n~pna~dde del~va~y l~els fcr beards~ frrterest in t~ mirpr cmsi~wts of EmJ(e is ~p~iwirg (Kerns~, etc,) Sins thYe are at least 4,000 identi~kble o~c~nts ol sa~e, ~w~ d ~ic~ are orai~ed tmde or hazar~ at ssfliciwtly bi5~ dose, the cfiallena ~n~ the regulatcrs will te ~at, UI anticipati~n d possible ragulat~i awes, ve~ve identifird GO tYPeS of dumieal ~i~fi ~o seek a meam of ~h~ir~. Pase ate: (3 ~aMl~tent carcirnsers (b) t~ese impe~tdnt c~Jrmnts ~hirh are at ~8~els, awfi t~t at a 60 cigarettes per day mranq~ti~, the irdivi~al exFeaae ~uld be above tbs amepbed thre~ld limit M3~ for the ~iorkir~ ernrimn~nt (40 b~ week)l lbese are ~nrmParised en slide x, ·O BATCo document for legal Services : Health Canada 21 May 1999 ~~lfuda~ntal Researd! Prc~a~Qmr, Yiro~drq ~ rmpna~t~, Y Vlis ~ largely lcnl ~· initiativa wra ne~ · Kuld Y to 1 alr~tia~ oi trhar~ q~es (a.g. +b ni~ata bpol~l~hensls)d~~p oi selective iil~atlcn (ot~nJ, BATCo document for legal Senlces : Health Canada 21 May 1949 ~i~Fsa~e ~t~ets ~ ~ ~ inbo~b~e rtgulaticn i relatirn to i~itability ~ ~ hY ci4ant~a is mnti~ Fartiptlarly ~ ~ ~ ~~ plblicatirn ot tba cigaretee saietY M (nrl ~1~ hYa ndnM ~9(80~ Qwk ~ ,~ teqirninl.~ ~ a ~ ~~' i. 1 reliable st~mlard ne~ is neded. Z Pe~tc~s~e data · prrnnt ~O~CtS is reedel. Ce~tain cb iea~n~Ps ot dgarettes lpdro ~plitabili~~rahrirs (drolfaace, e~ardfd tPbao;P, PaFer pe~B~bili~ ~ 4. an t~dml~ data · pebuk so mcdiiisd 1 ta be gathered. HO ~ e ~ taken lY t h8tiLM' f~bti~hP ol stadwds ~ TectrP~F~ in ptsdrq Viess r~m"jattcm ~ ~~ pieees ~'Esislatlm ~elative C dqaretteJ ~ iireahq an aAn~ed (i b fsdirq ag~eal)~ Elcanhlle C~RE~DL, ~ t$nli ~ ird~s~l, ~ btablldirg I nliahle ~ - initially Y ultinatelyl 'direct" ard lirdire~c'? ~b leadirq ~· BATCo document for legal Services : Health Canada 21 May l999 Ro;ress in the direR J~8tb~ is goirq veil - ~ r4ttim v, i~i~ om tabrie is able $ dis~inirate Ipnrhrtr, Datd fea cirPrmleref~ in slide x, BATCo document for Legal Services : Health Canada 21 May 1999 Side~tream ~issias So far t~are b~ve been m ~co~al mx~es to reg~late tha emissicm of sidestreem ~cm cigarettes, alt~u~ ttyl ISC has ma38 the follarfrg st~te~ent: nme tebacro i~stly ~ld pnsle re~iea~rh into ~ays of rerbrirq t~Y? Imclmt, irritarcy ard ctber daleteriais I~OFe*ties of sidest~i~ e~ke haa all tctem I~"~ n;rtbe~rmre, as interest in ~Ni~Pntal Teteoco ~Pke inreases, t~u? demard for a definition of the major rad mirnr c~qenents oi snke enittal hrm the ii: ed into t~ atsospar8 wil: ~par. Interestirq!y, the re~wt liu~f~s of ku visible sldes~Pam cigarettes in rJs ~we stirmlated trp anti~mddnl fadci~ers to ~estiw tt~ rasv~iblL sidestre~ an~a~e~s, It is inpc~t~t tp s~ess the difference in cteenishy ~, ~ side~t~na saoke - both sides~ ageirg ard t~u! ce~ib~ticn to ~S of e~ed smPlce are c~ten ~erlo3~d, ns · Agea (Total sides~e~m+ Wlaled SmP~ca) ~~ ~t,viU seek to relate EIS to cigarette sidestr~P yield sirce this is dipeetiym~annable· We need to distinSjisi~ Ibtal sidestr~e~ yield Ilrd tte vWble sidestream ~ield tt~t is chtnn used as a base fe~ ~erdal e~etitin~. ~p rptal sidesh.e~.Visible sid~estre~ + I~nvisjbla sidestreem Pn BATCo document for Legal Services : Health Canada 21 May 1999 gl~~'d~niqant~~a li~shaa dqaret~'~~ · ~ uhldptaf L1~ ~ · ir~e~se i inrisible lidcstrea (i lest d'~ ' iclpess~ redztimi· ~WISC p,2,90 BATCo document for legal Sorvlces : Heanh Canada 21 May 1999 Presentation to BATCo~ Board ·121t~ July 199P R&D Structure at SouthamDton April · BATCo, resumed management control ct R&O. Recognising two distinct des for 90's, set up two centres: 1. FRC ~Ll~i~ I 2, BtC Loss of 43 jabs (22 people) Ibtilgl.mU~i~M ien~~:~h .some shared services R~R, Baker: I,C, Blown Separate buildings · but adjacent R'e ~L13~ 1 S~Jlb~3 ~ct~V~~iL~ i.lhipn.3,macuim.Ec~rmrcli '(~; ~·id 3. o_ Terms of Reference (SLIDE.~~ BATCo document for Legal Services : Health Canada 21 May 1999 Product Devlnment SteerinPGrollo Terms of Reference To actively seek out and consider viable product concepts oi relevance to Be Group an a short to medium term time horizon, To initiate product development projects based on these concepts and progress these to the stage of implementation by an Operating Company, To make recommendations for specific product development and consumer testing in order to allow market validation by an identified Operating Company. This stage should involve further interaction between the Marketing Department, Millbank, the Operating Company and BATCo. Technology Centre (BTC). To ensure a steady flow of support technology necessary for implementation of the identified product and company needs. To recommend to the BMB the adoption of the annual programme and budget for all Group related POSG work within the ETC, To provide a forum for the exchange and distribution of product development information based on Operating Company experience. To evaluate, In terms of relevance to market needs, and to approve technical innovations emanating from Research, P BATCo document for Legal Services : Health Canada 21 May 1999 Prpiect FELT IL· !'~I' L~T~~4~tcl p~~:I.: ·' Original objective · front end liftifcr low delivery.: Flat "i,~ci p'0fil4not achievable, Projed!eo~iented to achieve a 9 mg, smoking like a13 mg. i,e. 6, i3C r more t~ste at low numbers, This has been successfully achieved · 9 mg, match far B&W 1* ~e Cn~~~c~~· CR·Yi·:- ~LLLI~· kIY~ Special Filter. ~-"ze'!! . C3" I~ I Ec,~' c~ ·r3 T:'.C t.Vc~':L~ ~t~t;.F~L7 r,r~ cCC~r.l~ ' ~L~: 2-e S~-~.~l· " ' " ·' ~*~F~t~U ~tC~(· Technology uses high level DIET 24%, high nicctine,tobacco (2.4%) and retains a high pressure drop filter cf, B8H, Product eharacterised by high reward for effort, Current developments: BAIZE US blended version to be evaluated against Marlboro and Marlboro Lights, 15% Y·l being used in one variant, Market opportunities now to be explored by Marketing, Proieet DEER Objective · use of waste tobacco in BATCo, companies, S companies (ITL, Canada; STC, Singaparel Sbuta Crur, Brazil; BP;T Kenya; Chiletabacos) are getting or have got the equipment, BATCo document for Legal Services : Health Canada 21 May 1999 1 __· Current product750/P tobacco/lS9b starch. For regulatory and taste reasons now developing a version with greater than 80% tobacco, and less starch, For US products where other recon, materials with ammonia are used there is still a feasible route for DEER usage, (SLIOE,,) Praieet Amteeh Objective: to investigate the potential benefits of Ammonia Technology In Virginia and Modified virginia products and to validate the usa of DEER technology as a possible route to introducing this technology~ Ammonia has proved effective in: ·,~ r~l · ~ '%s ·- !:'-' ' ' '' (a) reducing irritation r (b) enhancing body - B'' ~'""" in US blended products, Two proven methods of introducing ammonia · CPCL·II band cast (B&W) and EMERGE treatment of stem. Now urgent assessment of ammonia technology in relation to virginia and Modilied Virginia, A 313 matrixcovering 3 modes h of ammonia treatment for the 3 tobacco classes shown In O ~at ~ le SLIDE.,., o o N -· BATCo document for Legal Services : Health Canada 21 May 1999 This will: (a) clarify the merits of ammonia an vilglnia, (b) resolve the question of whether DEER t NH3 is capable of replacing "CPCL·O t~pe material" for BATCa, companies in bath Virginia and blended products. In the short term a simple trial in which a low delivery brand with high irritation is compared with the same product in which EMERGE has been used on stems is being arranged, Proiect LESS Objective: to produce a low sidestream product to match B&H Ultra Mild without sacrificing mainstream smoke quality. Atter extensive development work we have a product which is superior to competitive launches (Passpo4 Vantage Excel), in giving: · a marked reduction in visible sidestream · 50% reduction in particulate sidesbeam and reduced gaseous sldestteam relative to control, · good ash BA~Co document for Legal Services : Health Canada 21 May 1999 · no cff·taste based on panel testing, Product uses following technology: · 40% expanded tobacco FLI~ q · Special PUM paper CaC03 (5%)· Mg(3 (109b)·sodium acetate (5%j · Ratio filter- this is a Filtrona development. Dual · PE ribbon of high PD low FE backed with a conventional acetate filter, Allows high level of ventilation, thus reducing CO 6L1wla disproportionately to tar, i,e, achieve normal GO/tar, ~~U*re ~OY ~A Stw i~ About to sign supply and licence agreement with FDM (BAT has patent application), 3 further years exclusive, Consumer tested in France on B&H Ultra Mild this month; focus groups are being arranged in which a number of communication ideas will be explored, Large Mal will follow, Depending on the outcome usage will be broadened amongst low delivery products, BATCo document for Legal Services : Health Canada 21 May 1999 Probd GREEMDOT Orcdkr to podues low delivery pndld options 1 high nitotineltar retie end mod8td hr deliveries using materiels bd are noncolbdkur (n terms of RegulatolY euthorllies) but Dffer Impovld smoking mlchanlcs end sensory characteristics over current lew delivery pro~~~ FOCUb in NAtO on 4 mg. ~dP6 mg ~L pPdud b comp+ with a number of bnndl in Europe e.g. Yadbom UphyQd4 Camel lights, lard Extra (s/9 me~ rsnslb ToChnClogy: Core blend Rue t Budy (cased) · · glycerol added expended · 70Y. Flo~ I~ Balance of blend Orientel, Budy end Maryland · PloPYlene plyeel whole blend treeted with Ipaodl lecteteto emellorate srnoke high FE filter · piper lrontlCA baL~ Ya ensbles olb pet delivelY down without Mgh ventlletion. Piper retains tar well; vsnmdng to CA keepln4 PD up but wltb p effioient tar 1~L Preiect tested in 01P141L OP5111) (2,600 peo~4. Results ~afted~ a BATCo document for legal Services : Heath Canada 21 May 1949 I Other Proiects Although PDSG are not strictly short term, they are beyond the 'Explorato~ stage, Projects EPCOT (sxfruded wrapped cigarettes) and LEAST (radical sidestream reduction using alternative materials) are now located in FRC programme. AIM/SC 10th July, 1990 ·- V1 · BATCo document for Legal Services : Health Canada 21 May 1999 ~an~a~~ b~~··~·' 61~e-$r~ BATCo document for legal Services : Heath Canada 21 May 1999 ~KTC k~kW Y~-P Gb 1N THE SENITE OF THE UNITEO STITES MOYEMIEI 15 (LLCISL~TIVZ DAri MOIEMIER 6) ~989 IEIREDY 8111 TO AME#D TIE PIBLle BEALTB S~IV~eE ACT TD EST~BLISA A eEITER FOI TOBAeCO PR600CTS, TO IIFOII TEE PUILIC COI[EIIIIC THE I~ZAIDS Of TOBACCO USE, tO DISCLOSE AID RESTIIeT ADOITIVES Td sues PRDDleTS, ~ID TO IEQIIPE LABELIIC OF SICB PW001eTS TO PPOYIDE IRFOPMATIOI ~OMCE~RIIC SPCI PIODUCTS TO TRE POBL~C, ~18 FOI OTBER PBIPOSES, BATCo document for Legal Senlcls : Healn Csneda 21 Yay ~9B9 "SEe1902, FUNCTIONS OF CENTER "(A) IN GENERAL · tHE CENTER SHALL PERFORM FUNCTIONS THAT SHALL INCLUDE I "(1) DETERMINING THE EXISTENCE OF ALL ADDITIVES COHTAINED IN TOBACCO PRODUCTS TO ASCERTAIN THE NUMBER1 TYPE, AND AMOUNT OF ALL SUCH ADDITIVES fO DISCLOSE SUCH TO THE PUBLIC AND TO DETERMINE WHETHER SUCH ADDITIVES REPRESENT A SIGNIFICANT ADDED HEALTH RISK TO CONSUMERS Or SUCH PRODUCTS; III BATCo document for Legal Services : Health Canada 21 May 1999 "SEC,902 FUNCTIONS OF CENTER "(A) IN GENERAL - THE CENTER SHALL PERFORM FUNCTIONS THAT SHALL INCLUDE · "(2) PRESENTING INFORMATION TO THE PUBLIC THROUGH LABELS OR PACKAGE INSERTS CONCERNING - "(A) THE HARMFUL TOBACCO SMOKE CONSTITUENTS; ANO (B) ~HE ADDITIVES CONTAINED IN TOBACCO PRODUCTS;~I, BATCo document for Legal Services : Health Canada 21 May 1999 EXTRACT FROH SPEAKING NOTES FOR THE HONOURABLE PERRIN BEATTY, PCl MP, MINISTER Oi NATIONAL HEALTH AND WELFARE CANADA bNEW WARNINGS IN BLACK RNO WHITE WILL TAKE UP THE TOP 251 OF THE PACKAGE, AWD ONE SIOE OF THL PACKAGE RUST LIST THE TOXIC CONTENTS IN BLACK AND UHITE~ NEU INSERT LEAFLET, PLA[ED INSIDE THE CIGARETTE PACKAGE IH SUCH R WRY THAT, TO GET INTO THE PACKAGE, YOU MUST FIRST REMOYE THL INSERT. IT WILL .~· CONTAIN MORE DETAILED INFORMATION AND WARNINGS." BATCo document for Legal Services : Health Canada 21 May 1999 "THE TOBACCO IHOUSTRY SHOULO pURSUI RESEARCH INTO UAYS OF REDUCING THE AMOUHT, IRRITANCY AND OTHER OELETERIOUS PROPERTIES OF SIOESTREAM SMOKE FROM ALL TOBACCO PRODUCTS"· BATCo document for legal Services : Health Canada 21 May 1999 UK INDEPENDENT SCIENTIFIC COMMISSION bN S~H EUROPE'--GERMANY FEDERAL HEALTH INSTITUTE; GERMAN FOOD IAWI COMMISSION (EUROPE AGAINST CANCER PROGRAMME), USA DEPARTMENT OF HEALTH & HUMAN RESOURCES; CENTRE FOR TOBACCO PRODUCTS (KENNEDY BILL) CANADA HEALTH AND WELFARE, CANADA MIDDLE EAST SAUDI ARABIAN STANDARDS ORGANISATION BATCo document for Legal Services : Health Canada 21 May 1999 O rJ r vl ea p (n w M J z t w e t z_ e L1 pi w c~ p: vl ~n a p ~3 it; m n rn On ~> w r w 1 ~n w p ~I n B BATCo document for legal Services : Health Canada 21 May 1999 FACTOR EXCEEDING TL COMPONENL CARBON MONOXIDE 38x 36x ACRO1EIN METHYL ISOCYANADE FoRMre ACID FORMA1DEHYDE HYDROGEN CYANIDE 4x ACETIC Aero ETHYLENE OXIDE 3x NITRIC OXIDE 2x CAfEeHO1 1111111()11111111) 4 AHINOBIPHENY1 2 NAPTHYLAMINE NITROSAMINES BATCo document for Legal Services : Health Canada 21 May 1999