Lesearch Conference, Sydney, lot 5 On September 1986 A. L. Board Structure of Conference Last 7,*ar*s Research Conference concluded that a preferred format for future conferences would have two parts - a technical review of key activities presented by research sasagers/spoci&1ists, to be followed by a policy/strategy meeting involving only the Research Policy Croup (Rosearcb Co-ordivator plus R&D Directors). During tbo XPC meeting, the research sanaXers/speclalists would be asked to consider Issues to report to the closing sessiou of the 13PG. This format was adopted. These notes are consequently in three parts. 1. Technical Review of activities set against three of the important business objectives previously identified as common to the Group - (i) Snake Quality Improvement (Li) Response to Regulatory Authorities (ill) Cost reduction 2. Tt-e proceedings of the RPC seating. 3. The report on three Issues presented for consideration by the Research Managers: (L) Priorities (ii) DupIleatiou (ill) Competitive Intelligence and the ensuing discussion. Lima of the Conference I. To examine R&D activities and resources in relation to Group R&D seeds. 2. Critical review Of projects responding to 3 key business objectives. 3. 17C - to review orSanleation and strategy for R&D and related Issues. .4. Research Managers - to consider selected management issues relating to R&D and recommend to XGP proposals for action. 3. To agree future course of coordination of Croup R&D. job BAT Co LTD MINNELOTA TOBACCO LITIGATION 2 Technical Review : I a - 3rd September Business Objective 1 : laprovement of Subject Smoke Quality 1. Subjective Testing A pre-requisite to improving smoke quality is sensitive, reliable and appropriate sensory and consumer test systems. Traditional consumer testing has been aimed at Marketing Issues and has not always provided necessary guidance to product development and innovation. Recent method developments at 36W, ZATUKE and BATCF have improved this subscancially. Examples Include Dupont testing co guide development of statistical process control limits (B4W), a system to test novel products (DATUKE) and a postal market survey system (BATCF). However, the degree of co-ordination of R&D and Market Research functions any still need attention in some companies. 2. Process Factors B4W are putting a major effort behind smoke quality and inproveueuts based on recent leaf, reconstituted tobacco, casings, flavourings and primary process investigations. The emphasis on ammonia chemistry of reconstituted tobacco remains high. Additionally a Quality Maintenance prosramue has improved the chemical and physical consistency of the product. Souza Cruz are now incorporating reaction flavours from ammonium hydroxide - sugar reactions as a caning material for quality improvement in some blends. Souza Cruz' basic programme on curing, processinS and ageing variables, begun in 1981, is now moving to an Applications phase with particular emphasis on upgrading low quality tobacco and exploring different CLD profiles. However, it is important that basic research data will continue to be gathered since empirical observations will have limited general value. SATUKE have completed two low quality leaf upgrading projects, requested by Canada and Malaysia. The Canadian project used findings from the above Souza Cruz programme, as well as a 1B AT patent, a good example of inter-Coupsn7 Information pooling. 3. Chemoseasory Research The thostosensory Research programme aims to d1scover the chemical and physical properties of smoke Important to sensory perception, with coordinated contributions from D&W, ZATUKE and ZATCF - The co-ordination of this project was considered exemplary involving short term staff exchanges, regular workshops and good reporting. Practical work is as yet in its infancy but La y1eldIng some Interesting leads. Important anonS these is the role that C029 hitherto Iguared as a smoke component, may play In taste perception. Another co important implication for the future is the design of low _C@1. tar/nicotine ratio products, the tar perhaps augmented by och*r aerosol material to maintain sensory balance - Wbilst the conference BAT Co LTD - MINNE,6TA TOBACCO LITIGATION 3 could see merit in this approach to products for the future, it was agreed that our first initiative should be to review Group experience In producing low tartnicotine products from the cigarette acceptability standpoint. BATUKE Vill elicit views of the other CAC countries In producing this review. if we decide to proceed in the light of this review, It was augXested that all available options for pursuing this particular line be examined looking both 'in-house' and externally. Advanced Tobacco Products, manufacturers of 'FkVOR-, have made a proposal for working collaboratively with RAT in this area and this will be evaluated against the other options. Flavour/Taete Modifiers ZATCP describe a flavour-generating system, boxed on the reaction of ammonia and sugar# and improved by the addition of pectic and propylene glycol. The system was developed to influence global taste Impressions such as -fullness-, harshness' and 'blend character-. It con be used simply to develop casing materials or could be developed for flavour use by reaction with selected tobacco constituents. AltbouSh the ystam cannot be patented, it is being used by IATCIP an :elected commercial products. Future special applications ight be an expanded tobacco, sheet, etc. :ATCF a looking for a flavour manufacturer who can 'be relied upon to retain formulation details in confidence. Dr. SLqueira proposed that one possibility is to use Suvalan, flavour company owned by Souza Cruz. This will be explored. :ouza Cruz described the flavour research in Brazil: tobacco-based flavour (terpene fraction) add it to blend& con-tobacco flavours (fruit extracts) to reduce butt aroma and smoke Irritation tobacco treatment effects an flavour Souza Cruz have used fruit extracts to Improve poor Virginia and Barley tobacco grades and have applied the work to co 902 of their sales volume. Samples of various flue-cared samples 11 re available and other Group laboratories could evaluate then. Although the flavours have been sent round various Group laboratories, no other Company has used tb*u In the a a Future Flavour Workshops should really probe Group opportunities for application of such concepts and for distributing samples. The Flavour Workshop is seen as an excellent forum for exchanging inforascLon, on flmvours and presenting results on flavour research, and the concept wL11 be continued. co 4N6 _Mv. _t:rA. BAT Co LTD - MINNESOTATOBACCOLITIGATION Filters Filter research in relation to smoke quality was presented 'by SATUKE R&D. IQ the lost four years this bas concentrated on noke swirl and there is much evidence that this has & ;Ositive effect on smoke t&ste. The results from current consumer tests in Germany and Switzerland will determine whether various filter concepts will 'be developed further into products and should determine the future interest In swirl. The filter research area is at a crossroads In terse of what direction to take in the future. BATCr is currently the main Company doing filter development. 6. Biotechnology BATCF described the German biotechnology programme and its potential areas of application. The tobacco programme which is not leaf related but exploits the ability of tobacco calls to offer unique benefits (a binding character for special additives, low nit rosauines , etc) is only just getting underway, the major priority of the 2-3 people working on biotechnology being an a Government supported pharmaceutical project. BATCY called on Group members to seek areas of application of tobacco cell technology since if there are unique uses of this technique we are La an unassailable position from competition. Mr. Heard described the biotechnology opportunities in tobacco leaf improvements in terms of three strategies: the use of current techniques for the commercial improvement of tobacco, including developing a gene library develop the technical capability to select plants by genetic composition engineer tobacco plants to achieve defined commercial end points The Group now has the technological facilities to pursue plant breeding, tissue culture and, very shortly, molecular biology, aad we are In danger of pursuing a fragmented and perhaps low key approach. As a recent development Imperial Tobacco (Montreal) will be undertaking a 5 year biot*chnology contract to Increase total tobacco alkaloids and develop disease-resistant strains of tobacco, results of which they are willing to share with tb* Group. C30 _J@Nb -CU. A-I:b- Un BAT Co LTD MINNAOTATOBACCOLITIGATION 5 Mr. Heard expressed the view that if we are ever going to use the benefits of biotechnology on tobacco we suet begin a co-ordinaced and sore profound approach now - no one will do it for us. In discussion, the use of synthetic smoking aat*rials was suggested as au alternative route to tailored starting material but suffered the disadvantage of not being a natural tobacco product. klao, the use of genetic maps was questioned - practical application might be a better use of biotechnology rather that concentrating on fundamental building blocks. It was agreed that a technical group should be set up, chaired by Mr. C. A. Read, to set out a positive strategy for the agreement and co-ordination of the Croup biotechnology work in the different centres, and this will report to the RPC. Business Objective 2 : Response to Regulatory Authorities Session 1 : Maiustreas Source 1. Regulatory Mechanisms In the initial part of the session each country provided an overview of their respective regulatory authorities in terns of who they are, what they are likely to impose in the future and the nature of the interaction. Germany Three groups interact with the industry: L. Regional and Federal Government, in general Health Ministries. 2. The Vs 3. Groups such as Deutsche* I Fur Norsung Z-V. (DIN), ISO, Consumer Orgazisations, etc. Regulations relating to tobacco products have Increased dramatically since 19 70 - One example relates to aubient/pasaive smoking and the introduction of work place air concentrations (MAX standards). Aa far as SATCY is concerned the key Is to anticipate regu2ations/legislatiou and be In a position to respond to it. Austr*lia C=) Interaction Is with both the Federal and State Goveruseut N-0 Health Departments. A voluntary code exists with regard to co the CPH and nicotine deliveries. This code Is currently under -ftr- re,viev and will involve a change In the maximum pack printed J:b. deliveries and the printing of CO data. The warning label is _X@b also under discussion. C-ri BAT Co LTD - MINNESOTA TOBACCO LITIGATION 6 Canada Discussion takes place between the CTMC and the Federal Department of Health and Welfare. At present, the code Is voluntary but Is currently being discussed. Some local legislation exists regarding smoking in public buildings. Brazil No restriction at present but this could change both very quickly and with unanticipated severe requirements. Souza Cruz is developing an ongoing dialogue with members of the government in order to ninimise the introduction of legislation. United States The industry deals most frequently with Congress and tbo Federal Trade Commission on issues related to mainstream suoke. The FDA does not assert jurisdiction but would If any drug-like properties were to be claimed in advertising. The industry's relationship in unavoidably adversarial due to debate over causation. The VTC's involvement has primarily been In regulation of advertising. They are currently contemplating termination of cigarette testing due to budget pressures and a lack of support for the significance of delivery numbers. There are many regulatory issues now pressurlsing the industry, witb additional taxation and fire safety standards those most likely to be introduced. United Kingdom Principal interaction Is between TAC and the Independent Scientific Committee. ISC. The ISC advises the Minister of Realtb and vorks closely with the Department of Health and Social Security. The ISC will be producing Its 4th Report during 1987 which will deal with the following issues: Tar quality, biological activity, epidemiological analysis and nicotine Relative risk of different products Passive smoking Trends in snaking habits Action to combat smoking Additiv*s Research needs -CIA. BAT Co LTD MINNESOTA TOBACCO LITIGATION 7 Overall regulatory authorities were generally asking for reductions in tar and, La the Middle East, for reduction in nicotine. Carbon monoxide appeared to be of less interest. Regulatory authorities and anti-smoking Organisation* had spent such time examining the role of compounds such as mitrosamines and polycyclic hydrocarbons, but had not been able to come to any firm conclusions beyond advocating further research. 2. In terns of future scenario*, the following topics could become issues in the future according to Dr. R.E. Thornton:: 1. Dis-dichloromethyl ether in cigarette smoke 2. Radioactive compounds 3. Free radicals 4. Self extinguishing cigarettes 5. Substitutes 6. Heavy metals. 3. Control of Smoke Components The Group knowledge on controlling both major and important minor smoke constituents was reviewed. Important means of reducing components Lie in agricultural practice (or curing In the case of ni.trosanines) or in filter ventilation or tobacco weight reduction. Possibilities for selective filtration were reviewed. Stem treatments including shredding can alter delivery of specific components, eg HCN or CO. There was discussion of what specific smoke consonants need to be reduced or controlled In the future. There was, however, some lack of agreement on this point and the matter will be referred co the Scientific Research Group for an urgent in-depth consideration of thin very complex questiou. It Is imperative that SRG produces a pricritisation of those components backed by a rationale for each. Resources can then be allocated. 4. biological Testing Probable trends La tb* biological testing of tobacco products were reviewed. The Lace -in vitro' test only identifies potential carcinogens (on the basis of mutagenicity) and that additional tests are required to identify if tbi& potential can be realised. Southampton In currently looking at the possibilities in this area. It was also uoted that legislation say require the application of multiple tests. The In vitro Ames test is currently used in Hamburg, Montreal' and Southampton. co _Cb.. Jl@h. BAT Co LTD - MINNF@OTA TOBACCO LITIGATION Product Development SATCY described their project V4 which has the following objectives: I. To reduce the Ames specific activity of current products. 2. To develop prototype products with significantly reduced Ames activity. The approach Is based on the results of Project Rio but further basic research is being undertaken. One new finding of note is that high levels of ventilation significantly reduce Ames specific activity. Previous results indicated the reverse, and this apparent contradiction used* to be resolved. Both ITL and BATUKE are working towards developing products of low biological activity based on Ames testing for their 14 arkets. A small technical workshop an toxicology with representation fro= the three countries concerned would be arranged C=20 1-0 CO BAT Co LTD I TOBACCO LITIGATION 9 Session 2 : Sidestrean/Ambient Smoke 1. Possible Scenario Epidemiological studies underway in nine countries on passive smoking will probably be interpreted as giving adverse results (risk ratios greater than 1) although most studies are to crude that they cannot distinguish between any of the possibilities (no effect, positive effect. negative effect). Nevertheless, this will result in further pressures on the industry. In any event, false positive effects can be explained in terms of biassing effects, notably the misclassification of smokers as non-smokers. It is important that the shortcomings in such studies are pointed out. However, the IARC (1986 Monograph) says that where there is 2moke there is risk, and the ISC may ask the industry to modify or reduce sidestreas smoke. Social issues, particularly the pressures to clean up the environment resulting from the 'Green Movement-, are likely to override any scientific arguments and lead to further restrictions in 2. a abieut Smoke Monitoring BKTUXE R&D ambient roams provide controlled facilities unique in the Group to Investigate concentrations and decay of smoke components, and how these are affected by cigarette design changes. Nitrosamine levels In ambient smoke are leas than I mg/litre and only detectable at unrealistically high amok* levels. Ambient levels can generally be calculated from sIdestream emission values although nicotine presents an anomaly in having lower levels and faster decay rates than other components. Nicotine and CO levels measured by NATOLL RAD and in the Verband in familiar environments are 1/10 or leas than TLV a and lover than other published levels. The TAC Ls conducting other real Life monitoring as is the US Industry Group. Th* SAT/Gallab*r study at Harwell with labelled iodohexad*cau* shows vaporisation from particulates. Tbo analytical studies by rh1l1p Morris an environmental rooms (which Is in agreement with BATUKZ results), and on real life environments will provide data for the study being orSanised by the Verband. No epidemiological studies as such are planned by the the V*rband and the question of dosisecry studies is being examined. Future priorities are to rationalism sidestreau/sabient discrepancies and to investigate the activity of aged ambient smoke versus fresh sidestreas. --4 BAT Co LTD - MINNESOTA TOBACCO LITIGATION 10 3. Low Sidestreas Products Suppliers' cigarette papers which reduce visible snake do not decrease irritation and *dour and have other disadvantages. Rovever, Canada will conduct a very small market research exercise based on low visible sidestream with a Kimberly-Clark paper. Smoking properties have been made acceptable with a black tea extract. NATUKE X&D has shown that nicotine accounts for part of the sidestreas irritation. Stronger acid paper additives can reduce nicotine In sidestreas and will be further investigated. Reduction of the total amount of tobacco burned, with its accompanying reduction in total widestreau van agreed to be an appropriate general approach. Reduced circumference woes& to have fewer disadvantages than the ash problems from high expanded tobacco levels or high inorganic containing materials. Possibly a combination of the latter two nay provide a more normal ash density. It was felt tba product development activities on reduced circumference and reduced tobacco weights provide an evolutionary approach to sidestreas reduction and should continue. Wo immediate marketing requirements nor legislation an sidestrean yields are foreseen. Total industry approaches must continue to address the social issues. Project EMN (L) Proposal Development of a cigarette perceived as safe by our critics would ensure the continuance and prosperity of our business. ITL believe that whilst this long term objective say come to *aught, it should be attempted. As an approach ITL believe chat Ldentifization, by reference to external sources, of components claimed to be undesirable, is a first step to reduction to acceptable threshold levels by product modifications. Short and long term bioassays would be used to assess progress. Finally Titania-* and auti-oxidants could provide 'benefits whilst research continues into the mechanism* of disease. This approach should improve or at least scutralixe the hostile public Environment &aA protect against any competitive disadvantages. CD CC) -ftft co BAT Co LTD MINNESOTA TOBACCO LITIGATION Discussion The Canadian proposal refocuses the Issues with which the RAT Group and tb* industry have struggled since the aid 1950 ' Progress over the last thirty years has been evolutionary and, in the consensus view, vould continue to be so. Difficulties are seen in obtaining & reasoned external view an what smoke components should be modified. The view was repeatedly expressed In discussion that goal posts will change and that this applies even to accepted views on threshold*. The SRG will develop a consolidated view of priority components for smoke reduction but will necessarily be limited in time perspective and we can expect the targets to be reviewed and updated on a 'rolling basis'. Assuming that product modifications can be made to achieve some of these component changes, there remains the question of biological testing. Whether the chemical changes would affect test results is uncertain. The types of test would be those likely to be suggested by regulatory authorities, yet these may be of dubious validity. Despite these difficulties the Group programme should address these issues. At present, our policy La to support external research on biological testing systems and on mechanisms of disease but ITL would like to see 'in house' effort increased. Two alternative strategies which night (a) be required of us by Regulatory bodies or (b) be the basis of a product viewed by our critics as safer were discussed. The first, which is also evolutionary is to continue the reduction of car/aLcotine, ratios. The technology exists to provide significant changes but the problem of providing acceptable smoking quality has yet to be solved. The second, which is revolutionary, emphasises development of alternative nicotine delivery systems. both assume endorsement of nicotine but, assuming that this is achieved, the latter in the more likely to be perceived as safe. However, the former offers best prospects for a practical approach. ta summary, the Canadian proposal received limited endorsoa*vt from the Couf*reuce. whilst the ultimate goal is desirable there exists no recognised route to product modification to achieve it. Certain aspects of it are already, and will continue to receive attention particularly La the area of reduction of specif ic smoke components. Allocation of Group resources must, however, consider both the changes we nay be asked to Implement in a two to five year tine-frame, and Implementation plans for the alternative strategies. cc .X@hb BAT Co LTD MINNESOTA TOBACCO LITIGATION i2 - Business Objective 3 : reduction of Product Costs I.' Review of Options for Cost leductiou BATUKE presented a list of options and then presented details of several of these. One example in the nigh Velocity Dryer, originally developed for expanded tobacco, which can be applied to lamina and ate= drying. The advantages of this dryer are in the use of high temperatures and abort residence time. Another cost saving project (Project Lift) increases the expanded tobacco of a full flavour NATUKE blend from 8 to 12Z. By using a cigarette paper developed by R&D it was possible to make this change without significant change In 2. sensory properties. ow Density Cigarettes Ville outlined their progress in the production of low density cigarettes. Various filling power improvement processes were highlighted that had been instrumental in achieving these density reductions while maintaining cigarette firmness. With the exception of G.13 most of these processes had been developed by Wills or the RAT Group. Tb* ensuing discussion highlighted Wills' concern for density reduction because of the Australian excise system. This concern for density reduction was not shared by other companies such as B&V an' BATCF who put a higher emphasis on cigarette quality. Souza Crux Is becoming more concerned with cost aspects. 3. Particle Size Studies Thin subject Is being pursued by both Wills and BATUKE. The Wills project investigate* the effect of particle size on physical properties, such an filling power and loose ends. Ways of maintaining or increasing particle size were considered; these varied from changes in GLT through primary to modification of the making process. One of the concepts outlined was that of producing a controlled/restrlcted strand length tobacco. This concept went 'hand-to-hand with la edification of the maker to optimise tb* benefits of this concept. BALTUXE are also studying some of the effects observed with different particle size tobacco strands on. physical properties of the tobacco and cigarettes. The outline was given of a large project being carried out based on altering threshing node; tobacco Is being threshed under soft, normal and bard thrashing conditions. This work is being carried out with the asistance of GLT In the IDS. Brazil and Zimbabwe. :n order to ensure maximum co-ordination of this work, Dr. 9. Book from 3ATUKZ will visit Wills for two weeks during @_c October. CC AN, _Qh _D16 ON BAT Co LTD MINNESOTA TOBACCO LITIGATION - 13 - 4. Conearison of various Etta procossoo The Impact of various at*% processes on final product characteristics has been studied in considerable depth by ITL - This project was jointly run with BATCF and 34W. Canadian lamina and aces was treated in different processes in the different countries. The processes Included the STS process, shredded &tea, and the two modifications of high humidity drying. The filling power improvements of the different processes were listed along with the investments Costs. By optimum choice of process for *ten and lamina a 23Z cigarette weight reduction could be obtained. Potential yearly savings were presented. ITL presented their logic for adopting the STS process developed by BATCF. In discussion it was explained that no evidence of harshness was observed on repeated trials of the STS product. All this work gave a note of caution that the filling power improvement of some processes do not translate into the expected cigarette welght savings. A German view on a comprehensive approach to the most important working areas in the field of Research 4 Development was given, aiming especially at the topics: improvement of sucking quality improvement of acceptance of BATCF products by the con-user Resulting from this an overview of different process techniques aiming in this direction was given: development and production of RTS/RTT and the effects on cigarettes development of the STS process Jet process for Improving filling power The activities for reducing density during the last ten years was shown. An overview on the technology and know-how transfer from BATCF to other NAT companies (Switzerland, USA, Argentina. Australia. Canada, Brazil, Den2ark, Malaysia and the UK) including the above process techniques was given. 5. Waste Utilleatiou BATUXI presented details of their extrusion/expauslon waste tobacco utilisation project, Project Dear. An incentive for this work was the need for a reconstituted tobacco process uitable for smaller companies. It is an extrusion process :sing tobacco waste, starch, binding and &Sent and cc bustectants. This mixture is extruded through a standard _C@ft _Cb. -C:D. BAT Co LTD - I LITIGATION 14 - cossercial extruder wbicb allows for expansion on extrusion. This product is nov uud*rSoing biological. physical and sensory testing. The forecasts of cost of the product of Project Deer seems to compare favourably with other uetbods of reconstituting waste tobacco. The Additives Guidance Panel has seen no problem with this product to date. The meeting considered that there should be a comparison of the various options available to the Group for reconstituting waste tobacco and S&W offered to do a desk study to include technical opportunities for product improvement (notably smoke quality) an vell as cost savings. 6. Expansion Wills detailed the history of G. 13 use in Australia and summarised the advantages and disadvantages of G. 13 use. S&W gave a paper on their experience with DIET discussing the various formulations that they, have investigated and the results to date. BATUKE presented details on APEX. The need for a Group process for expansion was agreed at the R&D Conference La 1982. BATUIZ, having tried a large range of chemicals as expanding agents, have found two with synergistic effects which give greater filling power than either G-13 or DIET. This product has beter physical and chemical properties than DIET and has less effect on the taste. ZALTUKE plan to produce a small factory plant next year. The session concluded that no important approaches to cost reduction were being overlooked. Oc M-1 BAT Co LTD MINNE@OTATOBACCOLJTIGATION