B.A.T.: R. F_ -1). October24 to 27 1967. Present: Dr. S. 1. Green Sir Charles Ellis Dr. D. G. ":`elton Dr. R. 3. Grif"ith Mr. L. C. Laporte Dr. R. A. San.-ord Dr. F. Seehofer Mr. H. 1Z. Sottorf Mr. R. S. Wade Conclusion and Reco-nmendStlons The main conclusions are as follows: 1. Company sc,.entists should be fully involved in the 4'ormulation of company policy in the field of smoking and health. 2. Smoking is now irrevers4.bly associated with health. More legislat',on and governmental control can be expected. 3. Lessons can be learnt from the Strickman affair applicable over a wide range of activity. 4. Some attempt hould be made to establish the optimal levels of nicotine for smokers, to develop low T.?..M. norma I nicotine cigarettes. low T. P. M. low nicotine - cigarettes, predominantly health-orientated cigarettes and to consider more radical approaches to smoking devices and non-inhalable cigarettes. 5. Montreal and Har.-Narg will seek approval to develop a cigarette made predominantly of locally produced reconstituted tobacco. 6. Southampton will develop a cigarette incorporating all factors considered o. importance in bio-assay and aim to have It tested biologically. 7. Biotesting of Company products should be limited to products believed to be completely developed to a viable saleable proposition. CO 13 ATCo document for Province of British Columbia 20 April 1999 8. Tha Companies of the Group are generally weak and ,uln--rable in the development. of conventional ci-garetzes. We should examine the application of sc*e.-.t;"ic work to these prob ler-s. The closest wor'king relationships with thiose employed in marketing shculd be established. 9. Knowledge of the technical details of how people smoke could be of great value. 10. "'he attention of microbiologists within the Group should be drawn to the possibility of the necessity for microbiological production control. 11. The 100 mm. cigarette is probably in entirely the wrong direction. It could, hourever, provide an opportun.-ty to introduce extra long filters. 12. 1: was concluded that -memberS had found t'~e conference useful although the criticism was ex-aressed that there had been 4nsufficient detailed co-ordination o.' work programmes. 13. There should be further conferences of this nature and the majority present thought that the next meeting should he within the next six or seven months. C=) cc BATCo document for Province of British Columbia 20 April 1999 - 3 - o4 l Con'erence Dr. Green outlined the objectives of the conference as follows: a) To -- :---mne the research and deve'opment act"f".7 relevant to the Companies of the Group. b) To 4--ent.-y the main assumptions implicit in present activities. c) To identify the main objectives of research =nd development and to recommend any des.,.-able changes in objectives or procedure. I He pointed out that the objectives were very broad and should be cors-,rued to include other research centres such as Harrogate. Although additional topics could arise .-ro:n time to time, two major themes had been isolated, namely smoking and health and product development. 2. The -,.zetng approved the agenda structure, after a short discusslon. 3. Assurnotions Considerable discussion took place on the assumptions made by R. & D. sc,.ent!sts and these were listed without any attempt to justify them or to agree on their correctness at this time. as: Of the assumptions listed, the main ones were identified a) Research can be pro,fitable. b) -,here is a rnininum necessary level of nicotine. Smoking is a habit attributable to nicotine. T'-e form of nicotine affects the rate of absorption by the smoker. c) Smoking and health problems are susceptible to a research solution. d) If there is no inhaling, there is no lung cancer or respiratory disease. e) Smokcing has both physiological and psychological e I-ects. /4. cc 13 ATCO document for Province of BritiSh ColUmbia 20 April 1999 V.-lere w4ll be more government involvement in the tobacco 1nc-:us:ry in the .-uture. g) Company nc:-.-:nr=--:ical scient-,its are capable of making ;udgements on health matters. h) Salecnve f,".1trZt1tor of non-voiztile nmaterlals is poss-.1ble (4 . e. , aerosol part~.cles are chernically inho-nogeneous) i) Smoking and health matters cannot be entirely handled by legal and political moves. 4. The Presen: -----tr3n:nznt A number o~ factors were listed as being those a.-fecting R. & D. activity but over w`ic'- we Iave little or no control. The nalor ones were as follows: a) Le~-21 1!nr~ nras-:ures T*-e meeting heard surn:narLes of the American, Canadian and German posit-,ons and were unanirrous in re-=c'-.;ng the conclusion that the technical position on smoking and health is becomirg increzs,ngly complex and that the companies' scientists should be fully involved in the -or:-ula- tion of comp-any policy in the ~-ield of smoking and health. Sir Cl~arles said that in his opinion, the Industry should attempt to seize the initiative by some pocitive action. A number of suggestions wera considered and it was felt generally that some attempt should be made at the appropriate ti.-.Ie to br-ing together the industry scientists in the U.S. in order to explore possible action in this field. Dr. cited examples of the U.K. and especial.ly Germany. It was also agreed that company scientists can provide a positive approach in contacts with public authorities. It was agreed that smoking is likely .:) be associated w-th health continuously in the future and that it was not a passing phase. It was likely, moreover, that tobacco would be nvolved in legislation of a food and drug administration nature in respect both o.- product and Of manu-acture. The German situation regarding pestic4de on tobacco is indicative CO BATCo document for Province of British Columbia 20 April 1999 o-7 *,h-.s Zrond althoc;.- tob~-cao in Ger-nany alrezdy cc-nes under t~e food laws. 4.-e maecing d,.Zc-4ssed Ar-cel's smokirg rnater- .a I S and Tmpen.Z' Devellopments. -he po~ilt-on may be rencnec within a year or so where Celanese Corporation of America may a:tempt to exert pressure through the pu'-lic authorities to get their product I ;ncoroorated into cigarettes. In this connection, 4t was corsidered that the present arrangements were satisfactory. The present arrangement is that B.A.T. (MiMank) are in touch wit.'-, Ancel ard a relacionship which 's 'war-n' 'out limited to supplier and possible consumer. R. & D.r-. are testing S~-,! materials, and Amcel undertake to keep us .-ully Informed and rot to disclose publicly without prior cons-, Ita tion. 1-1-iere were reports that A.-rical '---d recently made a "tec-nological break- through", and if this were the case, both Germany and Canada wished to receive samples through Millbank when these become available. Germany would also I.,ke a small quantity of the current product. In the case of Im-jerial Developments the problems of communication were clarifted. Because of the A.M. & F. license to I.T.Co. (G.B. & I.). Dr. Green undertook to get further claril"ication with respect to the provtisior. of inforniation to Bristol of new developments on ?CL in Canada and Americz. c) External Rese~~rch ?r=;rerr7nes it was agreed t'-zit such programmes as those at the Universllty 0.- Kent-4c"-)r and at the Environmental Health Unit at Research Triangle, N.C. (Kotin) will influence company research' programmes and may also have other effects. For example, the -act that they will of necessity, publish their . Its should lead zo a reconsideration of our own policy on publishing and it was agreed that where results which we had obtained were likely to be covered by such publications, we ourselves should publish first. It was also agreed that we should co-operate in such programmes CD /6. 021 BATCo document for Province of BritiSh Columbia 20 April 1999 as a.- as pos:;I.Me. rn part-icular, Dr. Griffith "-cug'-r !-hat B.A.T. had 'ad a mcst favourable on Dr. Stokes of !:-e University of K_~=uckv dur,_ng ',!s recent vist to EL=Oa. -nas felt that K~-cn's v:or- coul-c! well provide :',e ccz!2s!on ~or t'-a cz-o:;erat*.c;n of the American !7!dus,_~,, a~ the sc,_ent4fc 'evel. '~-rovidled t.-.at cc-or-_~.na%on and contact is t*-rou;-, the :eio-active rase-arcl-- departments. I-, was men-ioned ti-at these programmes could also be supperted by ~he indus':-y, -perhaps at the expense of contributions to CTR or A~AA. d) was repored t-,-t bot'i aeynoldi aad American ,10,_-acco Company lhad recan-.1y greatly increased :'-e,r :_=cilities, p.-articula:11y in the area of product deve-lopment. it was agreed that this should be t=ken ir. to account in planning our own future act-vities. CDE suagested that pressure in development should not be allowed to erode the c, work considered necessary in each .eSaa7 la*--cra"Ory. The example o-- the 100 -,=. cigarette was c-=sidered and it was agreed this development was most undesirable from the viewpoint of smoking and lnealth, although It could offer the possibility oz i f introducing very long Filters. S. Generzl o~~ -R. 6, 1D. The following general objectives were defined following a discussion: 1) To insure t-ne continuazion o,: the industry and -Me prosperity of the compeny wWin the tndustry. The insurance aspect of research at this time is particularly Important. 2) To orov4de a technolog;cal basis for su.Aaining and increasing the profits of the company. bolth long and short-range. 31 To carry out some research work which is felt to be necessary if a satisfactory scientific advisory service is to be provided.. No attempt was niade at this time to delineate specific project objective s, but after general discussion, it was agreed that it is essential for the scientific research and marketing staffs to co-ope;ate closely in the'ir activities. /7. cc~ CN BATCo document for Province of BritiSh Columbia 20 April 1999 smolz= --!n~ 'n 2 rd Mr. x,~.rere preser., part of -.he Dr. Gr- *- wis n--' t:.-a-zant. Dr. Runeckies ,oined 'he meeting. It was dec,.2ed :':st ~.o ~4.sc-zss the F:IZEI. The pos;-Ion reg.ardling Can-ada, America and Germany was outlined- It was agree--: that the most imcor-.~nt feature was the commerclal attract,.on o-:ered by the publicit-1 wh'ch the filter had received, but there -.vas some indication that a granular bed filter may be of some Impor-tZrice with respect *0 taste. Vnis could be particularly so with respect to 'Arginia cigarettes if an alkaline addit_,ve were used which' might change the ratio of extractable to rcn-e.,,-tractable nicotine. The lessons to be learned from the Stnick-n-mn filter were that: 1) In the examinatf-cri of new ideas presented to the industry, companies must be demonstrably diligent even i- the idea does not appear to be attractive at ti-e time. The meeting was unanimous 'hat in the 1"--t of the preva4 ling ci rcumstances, Louisville had carned out a satisfac:ory examina- tion of the Strickman filter when it was first offered to the-, in 1966. 2. Companies should insist or inventors having some 'orm of patent protection and the presence 0"; witnesses, preferably lamr/ers, would be advantageous. 3. 1, nught be possible to market a hea Ith -orientated cigarette wtt-out p,-,.or biological testing. However, there has been some criticism of this at the Columbia press conference and the position is not yet clear. 4. The Strickman e%perierce demonstrates the general approach which rn'.ght be =ade to marketing health orientated cigarettes. This is to publish in the scientific literature and make disclosure possibly simultaneously through a public authority. S. We should re-examine the relationships between pressure,drop and retention performance of different types and forms of filter materials. Sir Charles Ellis surjeyed the progress of current work in the fteld of smoking and health. He was of the opinion that big advances have been made in bio-assay techniques for. smoke BATCo document for Province of British Columbia 20 April 1999 condensate paintinc, , and -.he: a num-*-er of different .-actors a. 1% ffecting biciog4c-al zctivfty are oeing reve--led and there is so.-..e ev,_4ence suggesting. smoke :rav onJ7 play a cor:r'b-.:1cry role In cZr=.no;=_nes4S. '17"'S leads to the conclusion that tf enoug` well d-rected ef~_-cr: were to be 3pplied, a cigarette could !:e wl-ch wsuld be of lower bio-assay activity, while ;:ossessing an accept-a*--le ZZE:a. ?*:--2 meeting agreed that _t would be -.vz;rt-.while to mZke --!uc- a ci~:zraz:e wit" lower zct"vity on :=;se skin provided this did not adversely a,-;-;ect the position %v_t.1i rescect to irritation and other -.actcrs. It wZs recognl=ed :*-at t~-,is im-olied certain aszump.nons z*--our the relevance of mouse skIn painting; but it was unlike"i thi s test would be replaced by cheaper, shorter and more meaning1ful tests for the next few years. A further argument is that iuch a "rnouse-sk:n safe" cigarette would be particularly valuable in public relations. in addit~cn to this biologic3l testing which could be undertaken or sponsored by the individual companies, it was suggested zhat each company rnig~-t well consider sponsoring at leBst a small orcgrz-1-ime of lon;er-range biological work, the main obiect of which would '-e to -amiliarize the company scienticts .vith tne problems involved, in order to apprec iate better the work currently being carried out in :he wKole field. The dl_-'_-.4cult!es associated with. inhalation studies ,ssed ar - -ely event were discL .d it was agreed that in the lik that no satisfactorj inhalation test could be found, It would be necessa,-/ to make an intuitive judgment based on cellular biochemical studies. Cons.1~2e:atic* was ther. given to mod!f4cations which could be made to cigarettes now and n the future. It was agreed that this could best be considered at several levels. 1) The improvemart of current brands should be continued by removing from the smoke, any substances judged to be hannful or alleged to be hannful, provided consumer acceptance is not adversely affected. 2. The development of lcw T.P.M., normal nicotine cigarettes should cortinue. In this connection, the use of filter additives, such as P.E.I. might be helpful since 4t render the nicotine more available to the smoker. 3. The develoomen! of a low T.P.M. , low nicotine cigarette should be expandee. This raises the CT uestion of the level of nicotine required and the consumer study by Bristol can be helpful in determining CM, /9 . cc CO BATCo document for Province of BritiSh Columbia 20 April 1999 zhis. Sottorf ;o:ntiad out t'-.2t t*-er-3 was evdenca th--r- --n German-Z ;~er czp,.'.a C_'Canatte incre- re-~ ~=r :he lower C_'nn:;t, *--e assumed t'-zt the min,--ium n~z3tina accept_=_~-le to t*-e s:nc.<-2r is the octimal "Evel' and some consideration should '--e given to 41 S07.e C~gzr'attas s'Ould be developec; '.vhich are entirely hea It'- -crientia red and in -,vhich health :ac-.Ors predom,.nate in the design. Such products must be subject to ccntinua! rev,_e%v and will. requ,re b1clogical tasting. In .,,.ew of the great e"ort involved in b-olog.,cal test-ng cf new cgarettes it should only be epplied to t~.osa kv--ich have already 6 fied t' ' t~s, - a,-,s- he raqu--aments of - -a, cost, etc., and s w'--,ch are, t'.-erefc:e, considered vial)le commercial Oroducts. Health or-entated c-.gErettes cught probably to be ShOrtef rather than longer. 5) A furt'-er a::Proac- could be tow-irdS Smoklnq articles which differ radical!,;, --rt-:n existing ctgarettes, for example, those constituted antirely from non-tobacco or the _'R7,_L device, o: even a cigarette aimed to be pleasartly non-inhalable. It was noted in passing that the trend towards cigarlets milder and therefore more easily inhalable was undesirable on health grounds. It was suggested that the development --' a number o' health-orientated cigarettes should be undertaken by the =ember laboratories. It was tentat'vely agreed by Montreal, Hamburg and Lousville that they would de~.elop or get approval to davelc;p a cigarette made predominantly of locally produced reco.-stituted tobacco. R. & D.E. , Soutnampton are already developing a cigarette which will incorporate all factors, recognised s irnoor--ant in the contaxt of with the ob 'jective of establishing the reduction in bi.l.gical ct.4vitv attainable at present. Dr. Felton outlined the present cigarette being examined in Southam,pton. This was 84 n.-n. including 20 mm. dual, filter with P.E.I., zinc acetate and sodium acetate. Amel4orants were being tested and the tobacco rod is 501". Burley 30% flue cured, both cut at 60 c. p. i. and 20',.' stem. The AlUEL device was discussed and opinion was divided as to haw -ar further development was justified. It was generally felt, however, that some Q-1 cc I-C BATCo document for Province of British Columbia 20 April 1999 .~Lrthetr de%eloprnan: Should 'ze Lindarta' ait' reipect to smokirg characteristics a-,,' aczepzance. eral' i7c1l::-.ved or. '_-as~c assuniptions which A ger Ia!-: c a d guided :-_n*K-_nc, in _ - ~-.' z_:nCki-9 r *-aalth- W~--le reco(;nis,n;; the imscrtZnca c- faztcrs in smokirg and t-e possitilty t-z s~D:ne smokers -ould accent nor-ricctire c4 ganaltes, it wms -ellt .har ricszina is imPcr-tz:n-_ -or -.a maicrity 0 smokers and thz' the form of nicotfne can be signif~c_=_ It was also considered that nicocine %vill be increasingly suiDject to attack. it was agreed that t'nare will be increasing government involvement in the izdustr-l. --'-e rneet4ng concluded that adsorbent filters such as charcoal wUll play a long-term role in c4garette design. Attz-ntion has racently been. drawn to t, e sugar content o' ue-ct:red t3bacco as a nossi'zie _:actor in respiratory disease. 1 he r-eeting noted t'at farmen:-4tion as a -neans of reducing the sugar con.ent is being tested in the 1ANUS programme. The use of catalys:s _:%nd additives to reduce benzpyrene was discussed. as wall as the recent patent b-,r van JLIsirg*-a on the add,.ticr, to c:-,;=ret:es o: --on-carcinogenic polyc, .fcl4 c hydrocarbons which. are SLPPOSed to transfer to the snnoke and f-unction as biological antagon-istz for carcinogenic hydrocarbons prodUced by pyrolysis. Vhe ;raliminery and tentative indications from results at Harrogate suggesting that potassium compcunds enhanced carcinogen:city were discussed in the context of the St. ?auli process and Dr. Green suggested that these considerations s'-ould be 1:om, a in in 'uture product develoomant work, Particularly in connec:lor a lealth-orientated ciga:ette. The evidence. however, is -..~;t strong enough to suggest that the existing St. ?aull. treZzmeat s-ould be changed at this time. It was suggested that it is likely that in the future, sorne attention -nay have to be given to the manufacturing process with regard to -nicro-biological control. Regardless of the outcome of current investigations in the field a"' smoking and health which are airned at assessing --a importance of micro-biolog;cal contamination, in the present political climate and with increasing government involve- ment, sooner or later to!Dacco manufacturers rrzy have to conform to standards sirzilar to those in the food and drug industries. it was agreed zhat this is a serious possibility and that members will give th.is Matter full consideration and draw it to the attention of their managements if appropriate. The situation in Germany regarding the stringent regulations for pesticide residues on to1bacco was explained and discussed. It was agreed that members would endeavour to obtain information BATCo document for Province of British Columbia 20 April 1999 rela'.4n; to the application requirements Of pesticides for insect control End Ito determine vr-et-er pesticides on the pronibited list could be replaced by acceptabie substitutes. Suc'- informz:tion. if available would be sent to Nlilnank ior Hamburg. Q:) Q:) BATCO document for Province of British Columbia 20 April 1999 7. -w-.z zn` were nrasen: '-me) D-.scuss-.on on 6:-.-.S -rubiec: lim-,ted to It'a development of new brz~nds of and --2 -cle Of R. & D. ir,-this activitv, par'.cularlv in Germany and Canada was described. It wz:s zoncl-udad :*a--t there is no easy tz; product develo,:-,ment, z-,~t -.s assentiz! to have t'-3 con,-nual tnvolvemart of mBrkanri~7, scier-ti!ic and leaf parionnel even before fte oroduct conceot w--s davelo!:~ed. Tl-.e zonz:-:hution of laborator,, work to development is, of necessity, somewhat li:mted. and sys-a:na::c .human smoking tests provide the predominant technique. de!P--n- mants tave a :-.ajor role in the latter work. Current la~Dorator,, tes:-z w.--.c'-, are coni.idered of val-de are tests for nicotine in the zooacco -nnd the smoke, sugar content in t'he tolacco and total pa:-:-culate matter in smoke. It .vas agreed, however. t --at a-tte=~ts sho~;ld be ma-de to firid out w--elther ,nee surement to,.al va=o;.:r z~'-ase and/or its pH a-or example, could prove use-'Ql and to extend, if possible, the application of extracta!:Ae n1cotine reasurements. %,Vith regard to '.~:e poss.:D.,e extension of the laboratory contrlbut4-on, Sir Charlas 'E'llis suggested sorne ccnsideration should be gi%en to a p*-ys-.ca1 measurernent relat.tg to the nicotine and the smoke aerosol and Dr. Seehofer descr--'--ed an interesting empirical test (CAM11-E-R) w*-ich is still under study in Hamburg. It was agreed that in the long run, a detailled knowledge of how snickars smo.'~e (pu-.- proLile, frequency voluma etc.) and now -e-av~oural pat:erns alter, could '~,e o~ great value in product developmant. It is pos--i-',le that if such a st,-d-! vare uridertaken. the market segment could be iden:ifiad with much more certainty and the pre-m-arks-' smoking e-.'a1L,--tic:.s could then be .made by pane' smokers corraspond-ng! to that segment. Such knowledge, of course, is prirner--Iv of Importance in the smnoking and health field, since .-, r.-axy validate the susceptible minority hypothesis. The first step is to develop the techniques required to car_-v out such a study and the meeting agreed that this ought to be done. 8. ?rocedural Ma-zers V" S i-t S Af,er discussion, it was agreed that visits by researc'- staf` to other laboratories within the group are essential 4-or collaboration, but they are also neccessZry to enable the research staff to do t-ei: own work properly. It was also sug;ested hat -In additior. meetings at the level BATCo document for Province of British Columbia 20 April 1999 c: the ::reia= cne, -ere csuld '--agree'. value in .Font meeting's a, --anch level. re ..e -.resent ;v_Ze:n o: is satisfactorl to all mambers, ;--ut it was genaraUy agreed that t~'are was insu-"icient fae-'back, to t'ne crig:nat:ng 1 _~borator:es. Cne point attartion was inadaq-_,_=te re!erenca to ea-riier work. c) rewawec' t-e new syste:ns being developed and suggested ti-.at a system, suc*- as this should '-,a cona;dercd for :ha group. The need for means that -.-.a group research requirements for i=~:-naticn retrieval should be looked at as a WhOlle, by sorneone w-o is a scientist and '-.zs experience w4th computers and data or--cessing. Dr. Green agreed to investigate the poss-,:Dil'Ity of rhis survey. d) ? _- ~ e nt S 71-a c=renlt pr-actIce in patent fikng -=rd renewal wit -in the group was reviewed. It was felt t"nat althcug'- pamicularly in Canada, macninerl pate-its had been ;)rcftta'_-1a, on balance too emphasis in *he past had '-een placed on process and mach.inery patents. In fulture, an attempt will be made to put much more amplInasis on prc-duct patents. t :t wzs agreed that w'.-ere feasible. group standards si-iould be adopted, 13ut t'-e local conditions for most comp_=nies in practice demand the adoption olz different standards. 1: was emp".-asisad that :--r f tt any smoke measuremenz, t'l-e num~~er of cigare es should he datermined 'ry the statistical sig=ificance sought. ~:Ilith t*-e atm of comparing relative results fron the peramoecJum b,-o-assay test. Hamburg agreed to circulate samples o: three types of cigarette to Louisville, Montreal, Sydney and Southampton. 0 ; ve r s iica.4on It was agreed that d4versification does affact the morale of researc, S'aff. It was also ;elt that in some companies tnere Is particulEr expertise available which could be helpful in diversilication exercises but wi-.ich is at present not used. Where laborZtory staft 'had been used in diversification BATCo document for Province of BritiSh Columbia 20 April 1999 '1 ~13 ~al: in :3 "Ive annc`ed E:z- C-n make a :z -s `ighly t.'-.9,/ sinould s;; PC a t~, -nt , n t'. I a r,-, -I, z:.e of wc;.-"- cn srd --.s nc: croded. was devejcp77.:-~ntj within C.;reiLa arld the culastton was :aised on ',*-d of other companies jotnlng. Dr. Grea:i s-m-c! chat in garerai, -.,s was contrary , S.A.- - - -0 pre-zen.. :. policy. T'.~e German comp-ny wa-z a me:n'--er :~-r very spec;zi reasons. G=-:-7~zn =mpany %-.r-.11 keep ::ie infcrn, ed C;- -'eve:o,~men.,-z and will ccpies of the B,-Ilecin fc.- circulation to :.=-u.,sv--Ile, Montreal, and Southampton. 9. The we:a Zgreed: 1) c-=n be -a:ofitable we are ir. an whe.-:? ne%-. producs cannot be -=Ittributable directly to researc 21 X~co:ine ~s important and thers -s probably a 7 e-:el of ncotme to wr:-' . I .. , Ic:-. far mz:n,! L,aoole C-.e e"ects o- smok,.ng are a-z-.`--~:-a-e. The form r4co-ne -arobaOly .s rate of absorption by t.-.e smoker. 3) G-r.-ernmen: involvement .r. !"-e =,'--acco industry w.~, --acome greater in t~',e fL,:,.::-e. 4) --'-a Ernokmg and --ealth pprc'--lem, is emarable to a researc- solution. This is a signi"cant, change in thinking and is a direct result o; research. 5) ?!-cdL:ct characteristics are important in mairitaining sales and for improving tne mar.