RESTRICTED R E S E A R C H C 0 H F E R E N C E RIO de JAMEIPU. BRAZIL 22-26 At If-,I I @T I Present: Dr C I Ayres Dr L C F Blackman Mr P Denton Dr P J Dunn Dr M J Hardwick Mr A L ilea rd Mr E E Kohnhorst Mr R G Nicholls Herm E Rittershaus Dr R A Sanford DrF Seehofer DrC J P de Siqueira BAT Co LTD MINNESOTA TOBACCO LITIGATION S U M M A R Y The Conference discussions were effectively split into three parts: Part I Subjects classified as Priority at the 1983 BCAC Conference Part II Other general issues of relevance to Group R&D Part III Specific revisions to the existing GRUC activities in order to formulate the Draft 1984-6 Group R&D Programme. Adverse trading conditions generally have led to a significant rationalisation of the balance of technical effort in CAC Compa Germany has temporarily el imi nated virtually all longer-term vio rk in favour of cost reduction arid product improvement. Australia, B&W and Canada plan to concentrate on new product development and on the maintenance and improvement of existing products and processes development. Brazil has severely restricted capital expenditure on R&D - although the tobacco processing research and Leaf Steering Committee pro are being maintained. These changes moan that to meet the 1983 BAT Industries guideline that Group R&D "should be maintained at a BAT Co LTD - MINNESOTA TOBACCO LITIGATION I evel suff i ci ent to, at least, keep pace technically with major competitors", the Group R&D Programme at Southampton must carry major responsibility for the Groups' longer-term needs for fundamental research aimed at generating radically new products and processes, and for strategic defence. The Research Conference continues to be essential in formulating and approving the Group R&D Programme and in helping generally to sharpen the thrust and effectiveness of R&D throughout the Group. Some possible changes to the organ at Southampton were outlined, the final details of whi ch had yet to be approved by the BATCo Board. A paper on Research Progress and Pol icy, to be submitted to the BATCo Board on 2 7 October, wi I I refer to the main conclusions of the Conference. The 1984-6 Programme wil I be prepared on the basis of the di scussions at the Conference. The draft programme, and the corresponding bud get expendi t ure , wi I I be presented for approval by the BATCo Board on 11th November. As in previous years, the approved Programme will then immediately be circulated to CAC Companies in the expectation that it accurately reflects the decisions of the Conference. Thcre would be time, however, to rectify any serious errors or omissions. 00 BAT Co LTD MINNESOTA TOBACCO LITIGATION -3 - P A R T I SUBJECTS OF PRIORITY BIOLOGICAL ACTIVITY 1. The CAC remit for Project RIO was interpreted in terms of two distinct but simultaneous approaches: (1) The evaluation of selected key national brands in respect of their activity relative to competitive brands, and then the modification of the basic design to give reduced specific activity using known technology - with consumer acceptance being maintained. Companies will select 4-6 brands and send them to Southampton - together with supporting details as to their broad construction and blend, and also an indication as to the reasons for their selection. It is anticipated there will be major progress, and an interim report, by mid-1984. (2) A systematic evaluation of chemical and physical changes that might achieve major reductions of the specific activity of model flue- cured and US blend products (of nominal delivery about 10 mg tar) with the aim of developing freestanding demonstration products of low activity. %J BAT Co LTD MINNESOTA TOBACCO LITIGATION -4 - 2 The f ol I o %-.,t ng bas i c. a s sumpt i o n s we re made f or the pr oj ect - The target is the allegation of carcinogenic response. - A League Table approach will be adopted, initially using standard smoking machine conditions to generate smoke. - The first screening test should be Ames using condensate. Later a refinement of the Ames test using-whole smoke will be available as a back-up test, but other tests (eg NMFI or P448 enzyme induction) wi II be used if at al I f easibl e within the programme In order to maxi mi se the available data. 3. The results from both approaches will be communicated wi thout delay to CAC Companies to help guide their own product development. In the meanwhile, a literature survey of all key knowledge on specific activity will be reported by the end of 1983. 4. Despite the favourable findings connecting Vitamin A with reduced risk of cancer, and particularly lung cancer, it was agreed that the comprehensive survey of the literature considered by the Conference leads to the view that Vitamin A (and closely related compounds ) does not present an opportunity for the cigarette industry dirdctly to influence human response to slooke . It was also agreed that the possibility of BAT funding medical research on Vitamin A should not be pursued. There is a need, however, to maintain a keen awareness of the subject, particularly with the vievi to understanding mechanisms that block the development of cancer. BAT Co LTD - MINNESOTA TOBACCO LITIGATION SIDESTREAM 5. The programme of work set up in response to the BCAC directive was supported - but it was stressed that the programme should consider the reduction of specific biological activity, as well as the reduction of visible smoke irritation and unpleasant odour . It should also consider the more general question of ambient smoke. 6. The possibility of achieving an exclusive BAT position in the development and manufacture of special papers was discussed. It was noted that the principal suppliers (Ecusta and Schweitzer) have refused to enter into exclusive arrangements. Also that the recent meetings of Dr Blackman, Dr Siquei ra , Dr Caruso and Mr Heard with Pi rahy , following earlier discussions with Wiggins Teape , had made it clear that Pi rahy does not provide a realistic route for special paper development. 7. In view of the above, it was felt that the joint work with dc Mauduit should be the main thrust of our efforts for at least tile shorter term; the two year lead time that the draft Agreement provides was as much as could be expected. The draft Agreement should, however, be re-examined to see if it can be extended to cover paper for self-extinguishing cigarettes, since the technology for one form of such products (slevi-burn paper) is not di to that for reduced sidestream products. 13AT Co LTD - MINNESOTA TOBACCO LITIGATION -6 - TOBACCO PROCESSING 8. Over a number of years. there have been experimental trials throughout the SAT Group which have led to significant product and process improvements. Although information an such work is now freely exchanged at the annual Processing Seminars, it tends to be specific to a particular plant design or operating condition. To provide basic data that can lead to general guidelines for the processing of tobacco in different designs of plant, it is necessary to undertake closely controlled experiments in which clearly defined grades of tobacco are subjected to wide ranges of temperature, moisture and time - and the resulting samples and/or products analysed with the most advanced chemi cal and physical techniques available. (a) Cheini ca I Chances in Processing 9. The Group Research Programme on tobacco processing in Brazil has been established to mon under controlled conditions the generation and destruction of flavour compounds and precursors during the whole sequence of tobacco processing froin curing and ageing to primary processing. Interesting results are emerging from the first two years work, and plans are now being finalised for tile next phase - an important aspect of which will be the deliberate change in selected process variables. 10. There was support for the GR&DC Protjramme which has been designed to provide supporting basic data from laboratory scale equi potent. The ult a is the development of predictive mathematical models that link tobacco fingerprints ( neutra I volatile, HIR and FT I P. scans) and smoke fingerprints (0/1-111) wi th subjective smoke evaluation (DELTA panel). Limited correlations to date are encouraging, and further evaluation of- tile validity of the coricept should he undertaken with urgency. BAT Co LTD - MINNESOTA TOBACCO LITIGATION 7 I 1 New analytical techniques for measuri ng key components are bei ng devel oped at GR&DC, and it i s envi saged that in the subsequent phases of the Brazilian Programme there will be greater need for use of scan techniques. There remains, however, the acute problem of obtaining Government authority to import the necessary scientific equipment. 1 2 A brief report was given of recent German work in which applied chemical analysis has led to improvements in two commercial processes (St Pauli and vertical lamina air dryer). (by Physical Changes in ProcessiL2 1 3 There was also good support for the GR&DC programme to obtain and interpret basic data on the ef of temperature, moisture, time and size reduction on the physical properties of tobacco. The programme is now well underway. 14. The aim is to develop predictive models that link certain physical properties of both tobacco leaf and tobacco strands (elastic moduli, tensile strength, density, shape etc) with the bulk properties of the final cigarette. During the year a preliminary study of cellulose acetate fibres, and made up filter rods, has proved useful in providing ideas for the formulation of the above programme. As soon as possible the models should be tested in one or more real-life situations. 15. An important requirement of this programme is to develop reliable techniques for characteri sing the relevant physical properties, and the progress that has been made by Germany will be incorporated into Tu GR&DC work. (__j I BAT Co LTD - MINNESOTA TOBACCO LITIGATION 8 - SMO C07!DENSATION AND MACHINE TEST PROCEDURES 16. Compensation is now attracting the interest of Government and medi cal authorities in many parts of the world. Thi s i s based on the increasing number of new studies and, in part, by the evidence submitted by the industry to the FTC in the Barc lay i nvesti gat ion - much of wh i ch has already been communicated to Government authorities in Australia, Belgium, Fi nland , Ho I land , Svii tzerl and and the UK. 17. There is now an urgent need to assess whether there are ways in which the industry can ei ther counter the situation or alternatively turn it into a commercial advantage, 18. A direct consequence of this growing interest in compensation is tile possibility that the FTC, and other authorities, may call for a change in the standard smoking machine test procedure for all products. If this were simply to be a modification to the existing standard procedure (increased puff volume, duration or interval) the effect would be to increase delivery levels but it would probably have little effect on League Table rankings. A more extreme possibility is that, an entirely new test procedure could be developed, eg a biological index or a Herzfeld-type multiple delivery index. 19. Either move would weaken the concept of I Ott tar and would both confuse and concern the smoker. Operat i ng Companies around the Group should, therefore, do everything possible to defend and maintain the present standard test procedure. If, however, the FTC or any other authority takes action to change the procedure the strategy should then be to stretch out any discussions (both with the authorities and later at ISO) until exhaustive stidies have established that an alternative procedure is in fact more relevant. BAT Co LTD - MINNESOTA TOBACCO LITIGATION 9 20. In the meanwhile it is essential that we should increase our own research into how and why people smoke: eg what the smoker needs or gets from the cigarette in terms of nicotine and other sources of satisfaction. Until we have s uch knowl ed ge we s h al 1 n at be i n a pos i t i on to judge what would be best for the industry in the longer term. 21. In the 1977 BAT Smoking Behaviour Conference it was openly stated (and later published) that, while the standard machine deliveries were based on arbitrary machine settings, there is experimental evidence to show that the smoke uptake of the average human smoker is not widely different from the standard machine delivery. Thus we have a good basis to engage in open dialogue with authorities - with the aim of encouraging a joint approach if a new test method is demanded. 22. In such dialogue, the opportunity should be taken to inform -authorities that contrary to the widely held belief that the average smoker gets more smoke in the later puffs, smokers in fact tend to do the opposite. Thus the smoke delivery profile of successive puffs differs from that of a standard smoking machine, which produces an increasing amount of smoke in the later puffs. Much of this information has come from more recent ITL results on puff-by-puff analysis using a 4 - duplicator used in a modified mode. 23. It was thought particularly timely and relevant that ITL should attempt to influence the protocol and techniques to be used by Or Rickert (Labstat, Ontario) in his proposed major compensation study on 3000 Canadian smokers. 24. Whatever the outcome of the various publ ic debates on compensation and test procedures, we must aim to use our knowledge to develop products that give improved smoker satisfaction. The Concept of 'smoke elasticity' can be Cx f)e CL ed tu play an important role. C_n BAT Co LTD - MINNESOTA TOBACCO LITIGATION -lo- INHALATION AND PRODUCT IMPROVEMENT 2 5 There are two potential ways of modi fyi ng the cigarette for product improvement: (i) reduced retention of smoke in the lung (ii increase of the level of irritation to reduce depth of inhalation. 96. Although it was appreciated that irritation may be changed to give a product advantage, it was agreed that the research should concentrate on the first route, ie the modification of the smoke aerosol to decrease the amount of smoke retained in the lung. An intpo rt. ant criterion is that any changes made to the product must not damage smoker acceptability - indeed the aim must be to increase it. 27. The basic assumption is that nicotine, which is almost certainly the key smoke component for satisfaction, is fully released to the body system before exhalation takes place. It is essential, therefore, to attempt to quantify tile change in chemical composition between inhaled and exhaled smoke under different conditions of smoking, ie shallow, medium and deep inhalation. The absorption of nicotine via the nasal cavity should also be investigated. [See also later section on Nicotine, paragraphs 33-35.] C=) BAT Co LTD MINNESOTA TOBACCO LITIGATION BENEFITS OF SMOKING 28. The draft report by tir Ferris on the significance of smoking in every day life was thought to represent a major response to the CAC directive. It was agreed that when the report is formally issued, CAC Companies should consider whether the information already reviewed is summarised in a form suitable for use by Public Affairs to support the practice of Smoking. 2 9 .Any decision to Increase research effort will be decided only when the responses of the CAC Companies, and of BATCo Public Affairs, have been collated. 3 0 .It was felt that we should not use the expression "Benefit of Smoking" - particularly in external circles - but should substitute something like "The Significance of Smoking to the Smoker". 3 1. The possibility that BAT Industries might provide some financial support to the com pro liens research project of Prof Ivor Mills at Cambridge into compulsive excessive behaviour (eating, drinking, smoking) was discussed. Although the results are unlikely to have relevance to normal smoking (since much of the work has a psychiatric base) it was agreed that, subject to lawyer approval, there was public relations merit in supporting the project. J:b- BAT Co LTD MINNESOTA TOBACCO LITIGATION EUGENOL 32. Recogn i z i ng t he pot ent i al f o r eu ge n ol - f I a voured c i ga rettes. in countries outside Indonesia (eg Australia, Malaysia, USA), support was given for the proposed limited GR&DC programme to assess the pharmacology, biochemistry and toxicology of eugenol and its smoke products. The study will include the possible interaction of nicotine as a stimulant with eugenol as a depressant. Significant progress can be expected on this project within one year. C=) co BAT Co LTD MINNESOTA TOBACCO LITIGATION -1 3- P A R T I I OTHER GENERAL ISSUES NICOTINE 33. Th e growi nq co ncern a b ou t c om pe ns a t i o n i s f o cu s s i ng a tt en t i on on the r o I e of n i c ot i n e i n t he smo k i n g pr oces s .It was agreed t hat we in u st know a s much a s pos s i b 1 e about : - f acto rs that af f ect the tra ns f er of n i cot i ne from leaf to smoke aerosol - f acto rs that i n f I uence the rate of t ra ns f e r of nicotine from particulate matter to the vapour phase - the contribution of nicotine to smoke sensory characteristics (including harshness and irritation) - the site and mechanisms of absorption of nicotine within the human system - the way nicotine stimulates both the central nervous system and the peripheral organs (eg heart and lung) - the me tabol of nicotine within the body, including rates and equilibrium levels. 34. The developing programme of research at Southampton was supported, albeit th at greater emphasis should be placed on direct human studies rather than'o'@ .an im a I - particularly in view of recent major advances in brain pharmacology. It is envisaged that much of such work will be undertaken under contract. -Chw BAT Co LTD - MINNESOTA TOBACCO LITIGATION - 1 4 - 35. It was proposed that a senior person at Southampton should be responsible for coordinating all the relevant interest and work throughout the Grotip . There is an urgent need to prepare a status review on all major aspects of the plia rma c o I o g i ca I i n f 1 uenc es o f n i c ot i ne i n t he smoki ng process. INTE R Or TECHNOLOGY 36. While-the underlying principle of the open-door policy was fully supported, it was felt that guidelines for the interchange of product and process innovations should be agreed and circulated. These guidelines should cover the security of information, and also the need to limit the du pl of applied development. 37. For product innovations this should be ensured by the is-SC and by the proposed meetings of CAC Marketing Directors with Heads of R&D. The Production Conference is a relevant vehicle to cover process innovations. Dr Blackman should discuss the need for guidelines with Mr Pritchard. RECENT GERMAN DEVELOPMENT OF COMMERCIAL PRODUCTS Pursuant to the new open-door policy, details were given on the following: (a) Filter Variants 38. A description was given of a nu mb of filter designs capable of directing smuke to specific areas of the mouth. This technology has led to patent applications. Results with other novel filters wh make use of the principles C=) of I elasticity' ticr,-, ,ji von . C71%. C=) BAT Co LTD - MINNESOTA TOBACCO LITIGATION 39 The who le area of f i I ter dev elopment based on the use of filters to influence smoke dynarni cs in the mouth is regarded as pot en ti a II y of great importance to the Group. (b) Reduction of Smoke Irritation 40. Details were given of a study of the effect of cigarette design parameters and blend composition on smoke irritation us technique of headspace analysis and vapour phase scan to follow the important chemical changes. This work had indicated directions in which smoke chemistry should be modified in order to change the level of smoke irritation. (c) Pyrazine Flavourants 41. It was described how a combi ned approach of the flavourist and the chemi st had led to an improvement in the taste and flavour of a commercial cigarette. These studies were particularly concerned with the distribution of different pyrazines in the individual components of the blend. JUBIOUS PAST RESEARCHES 42. The underlying principle was understood, but it was agreed that Dr Blackman should talk further with Herr von specht and Dr AdIkofer to ascertain what positive action might be appropriate. Qualified third-party comment was thought necessary to make any real advance at this late stage. Xb- CY,% BAT Co LTD - MINNESOTA TOBACCO LITIGATION -1 6 - INTERBAT 43. With the growing interest and use of INTERBATO CAC Companies should be reminded that facilities are available to limit or block access to sensitive reports or information. CONFERENCES/TECHNICAL EXCHANGE MEETINGS 44. The following technical meetings have been held in the past year: September 1982 Research Conference Canada November 1982 Production Conference UK December 1982 Combustion Conference UK March 1983 Environmental Smoke Meeting U 11% March 1983 INTERBAT Meeting UK A p r i 1 1983 Sinoki ng Behaviour Conference USA May 1983 Tobacco Processing Meeting Germany May 1983 Biol ogical Meeti ng UK May 1983 Review of GR5DC Programme UK June 1983 Flavourist Conference Germany July 1983 Computer Modelling Conference UK August 1983 Research Conference Brazil 45. It was agreed that tile in had been a highly effective means of exchaoiging technology throughout the Group, and that a similar level should be maintained in tile future. r%0 BAT Co LTD - MINNESOTA TOBACCO LITIGATION 1 7 - 46. The fol I owing were thought to be appropriate at this stage: Flavourist Conference Baw Late 1983 Biological GR&DC Spring 1984 Programme Review GR&DC May 1984 Smoking Be h a vi our (with Marketing) Canada July 1984 Flavour Research ? Late 1984 Nicotine GR&DC Sometime 1984 Subjective Testing ? (LCFB discuss with Mr A M Heath) Research Conference Australia August 1984 GROUP PRIORITIES FOR CENTRAL R&D 47. The draft statement prepared in response to the CAC .rcquest for a simplified statement of priorities within the Group R&D Programme was supported - albeit that the statements for 1984/6 should emphasise how the longer- term researches underpin the shoritcr-term work of oper at companies. It was also felt that the document for the 1984/6 Group R&D Programme should more clearly indicate the anticipated key a chievements and timescales while continuing to give full details of budgets and staff allocation. BAT Co LTD MINNESOTA TOBACCO LITIGATION -18 - P A R T III GROUP R&D PROGRAMME 1984-6 Th organisational changes proposed for the activities at Southampton (greater se p a rat ion of 1 onger-term basic research and the more rapid application of current technology) will have a bearing on the overall shape of the Group R&D Programme. The ch an ges sh au l d st re ng then the Group R&D programme - which will be formulated in the light of the Conference discussions. In ad di ti on to the poi nts recorded in Parts I and II, t tie fol lowing speci f ic rcconimend a ti on s were made. (These recommendations related to the Work Areas as numbered in the current Programme document. The proposed re-organisation of programmes will result in a new set of Work Areas and nu tab for 1984-6.) 01. BIOLOGICAL The relatively limited specific resources must be directed prima at Project RIO. The timescales for the key stages in the two approaches outlined in Para 1 (Part I) should be indicated. They are of equal priority. Care should be exercised in respect of over-dependence on the Ames test for mutagen as being a marker for carcinogenicity. Other more direct tests should be included if at all possible. 02. FILTERS The main emph as is should be on fundamental studies of the we ch an sm of parti cl e capture , and on the i nrl ucnce of f i Iter construction on sensory response; -J BAT Co LTD - MINNESOTATOBACCOLITIGATION -1 9 - There should be a major review by the end of 1983 of the probability of success in continuing research into selective filtration. It is anticipated that there will be a reduction of effort in 1984 - though contract research at universities may be attractive. The priority gas phase chemicals to be removed were agreed to be oxides of nitrogen, al dehydes , hydrogen cyanide and nitrosamines. Fundamental research on filters will no longer be a separate Work Area, but will become a sub-section of a new and cnlarged Work Area to be Headed by Dr Baker. 03 N I Similarly, nitrosamine research will no longer form a separate Work Area but will also be a sub-section o's 'Dr Baker's new Work Area. Research should continue to be directed at both the origin of nitrosamines from tobacco nitrogen compounds and combustion, and the possibility of reduction by selective filtration. Th programme of work might well be influenced by the outcome of the nitrosamine conference in Banff, Canada, in September 1983. 04 I TEC II 1101-OG I ES While recognising the overwhelming nmed to identify and develop radically nevs products and processes, Future Technologies will no longer be a separate Work Area. CD BAT Co LTD MINNESOTA TOBACCO LITIGATION -2 0 - It was thought es sent i a l that one t ru I y imagi native scientist should be free from project work to devote his thinking to the future forms of products and processes. 05 COMBUSTION Thi s Work Area will be broadened to cover other aspects relevant to the burning cigarette viz t h e mechanics of aerosol formation, the generation and control of sidestream and nitrosamines and fundamental filter research. There will be a change of title probably Smoke Research. 06 SIDES TV EA14 Basic research into the generation and control of sidestream will be covered by the above new Work Area headed by Dr Baker. The development and consumer research of products based on new designs of cigarette and new papers will be the responsibility of the proposed Product Technology group which is most likely to be headed by Mr Heard. There should be close interaction between Marketing, Public Affairs and the research and development on reduced sidestream carried out in GR&DC and CAC laboratories. BAT Co LTD MINNESOTA TOBACCO LITIGATION 07 HUMAN SMOK ING/SMOK AEROSOL 08 PSYCHOLOGY MU SENSORY TESTING The pro gr anime of work on human smoking, psychology and sensory testing should be brought together to reflect the urgent need of the Group to respond to the pressures outlined in Paras 16-24 (Part 1). 09 SMOKE TASTE AND FLAVOUR IMPROVEMENT Although a broad approach was agreed necessary at tire start of the programme, it was felt that effort should now be concentrated on selected areas thought most likely to lead either to commercial application or to advances in sc understanding. Again, although the origin of the work was to au green the taste and flavour of low delivery products, the need to enhance taste and flavour of 10-15 mg products was also stressed. Mouth sensation is a very important aspect of the work. LCAF AN[) BIOTECHNOLOGY The work. for the Leaf Steering Committee, and the development of scientific descriptions of leaf to improve tobacco blending and utilisation, were regarded as the priority areas. Work on the microbiological route to smoke flavourants should be determined by Work Area 09. CON BAT Co LTD MINNESOTA TOBACCO LITIGATION -2 2- 11. TOBACCO PROCESSING In the proposed reorganisation of activities in the Process R&D group, effort should be concentrated on basic research into the chemical arid physical properties of tobacco and cigarettes. 12. TOBACCO EXPANSION Although the prospects of developing a new expansion process novel to BAT are poor, the most promising approach (superheated steam plus solvent) should conti nu to the stage of a major review in Pt 13. NOVEL CIGARETTE MAKING TECHNOLOGY Work should concentrate on the three developments involving thermoformable paper which are regarded by the MPUC of potential commercial interest, viz i a new filter/product, possibly using spin moul di ng , of high taste:tar ratio i i novel products in which smoke distribution in the mouth may enhance smoker preference (M) exploration of the CSF/ I filter concept developed for low CO products. Research shoul continue into radically new product concepts as ideas permit - guided in part by the outcome of the discussion on Future Technologies. CO BAT Co LTD - I TOBACCO LITIGATION -23- 14. PROCESS CONTROL AND PIIYSICAL TEST METHOD DEVELOPMENT While recognising the considerable past contributions from GR&DC in the general area of control instrumentation, much equipment is now provided by machinery and instrument manufacturers. It was agreed, therefore, that there should be a major reappraisal (most probably a significant reduction) of work in this area, subject to suggestions froin the CAC Companies as to future key needs. Expertise and facilities will continue to be available to nice such needs. The work will, however, be integrated with Work A 15 under the new general title Test Method Development. 15. C11@1-11CAL TEST 14ETIIOD nEVELOPMENT & ANALYTICAL PROJECTS New methods VI continue to be developed as appropriate. The analysis of ambient smoke was regarded as a priority need - to provide firm data to counter misleading statements in the literature and the media. LCF B 1 3 . 1 0. 8 3 BAT Co LTD I TOBACCO LITIGATION