B.A.T.: R. E. r). CONFERENCE - M0'&%'TRE'1%L- October 24 'to 27 1967. Present: Dr. S. T. Green Sir Charles Ellis Dr. D. G. Felton Dr. R. B. Griffith Mr. L. C. Laporte Dr. R. A. Sanford Dr. F. S*ehofor Mr. H. E. Sottorf Mr. R. S. Wade -Conclusion and Recommendttions The main conclusions are as follows: 1. Company scientists should be fully Involved In the formulation of company policy In the field of smoking and health. 2. Smoking Is now irreversibly associated vAth health. More legislation 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 should be made to establish the optimal levels of nicotine for sr-jokers , to develop low T. P. M. normal nicotine cigarettes. I ow T. P. M. low nicotine cigarettes, predominantly health-orientated cigarettes and to consider more radical approaches to smoking devices and non-Inhalable cigarettes. S. Montreal and Hamburg will seek approval to develop a cigarette made predominantly of locally produced reconstituted tobacco. 6. Southampton will develop a cigarette incorporating all factors considered of importance In bio-assay and aim to have it tested biologically. 7. Mote Sting of Company products should be 11 mited to products believed to b* completely developed to a viable saleable proposition. cc cc BAT CO LTD - MINN A TOBACCO LITIGATION 8. The Companies of the Group are generally weak and vulnerable in the development of conventional cigarettes. We should examine the application of scientific work to these problems. The closest working relationships with those employed In marketing should be established. S. Knowledge of the technical details of how people smoke could be of great value. la. The attention of microbiologists within the Group sbould be drawn to the possibility of the n*c&sslty f6r microbiological production control. II. The 100 mm. cigarette is probably In entirely the wrong direction. It could, however, provide an opportunity to introduce extra long filters. 12. It was concluded that members had found the conference useful although the criticism was expressed that there had been inefficient detailed co-ordination of work programmes. 13. There should be further conferences of this nature and the majority present thought that the next m&etinq should be within the next six or seven months. co co BAT Co LTD MINNESOTA TOBACCO LITIGATION 3 objectives of the- Qonference Dr. Green outlined the objectives of the conference as follows: a) To examine the research and development activity relevant to the Companies of the Group. b) To identify the main assumptions implicit In present activities. C) To Identify the main objectives of research and development and to recommend any desirable changes in objectives or procedure. He pointed out that the objectives were very broad and should be construed to include other research centres such as Harrogate. Although additional topics could arise from time to time, two major themes had been Isolated, nctnely smoking and health and product development. 2. The -.meeting approved the agenda structure, after a short discussion. 3. As Considerable discussion took place on the assumptions made by R. & D- scientists and these were listed without any attempt to justify them or to agree on their correctness at this time. Of the assumptions listed, the main ones were Identified as: a) Research can be profitable. b) There is a minimum necessary level of nicotine. Sm. oking Is a habit attributable to nicotine. The 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. 0) Smoking has both physiological and psychological effects. co co CD BAT Co LTD MINNESOTA TOBACCO LITIGATION 4 There wilt be more government involvement In the tobacco industry in the future. Company non-medical scientists are capable of making judgements on health matters. h) Selective filtration of non-volatile materials is possible (i. a. , aerosol particles are chemically Inhomogeneous). 1) Smoking and health matters cannot be entirely handled by legal and political moves. 4. The Present EnvIronment A number of iactors were listed as being those a R. D. activity but over which we have little or no control. The major ones were as follows: a) D-mal and political pressures The meeting heard summaries of the American. Canadian and German positions and were unanimous in reaching the conclusion that the technical position on smoking and health Iz becoming increasingly coniplex and that the companies' scientists should be fully involved In the formula- tion of company policy In the field of smoking and health. Sir Charles said that in his opinion, the Industry should attempt to seize the initiative by some positive action. A number of suggestions were considered and it was felt generally that sorne attempt should be made at the appropriate time to bring together the industry scientists In the U.S. In order to explore possible action in this field. Dr. Griffith cited examples of the U.K. and especially Germany. It was also aC.re*d that company scientists can provide a positive approach In contacts with public authorities. It was agreed that smoking is likely to be associated with health continuously In the future and that It was not a pas.sing phase. It was ILkely, moreover, that tobacco would be Involved in legislation of a food and drug administration nature in respect both of product and o! manufacture. The Gwman z!tuation re pesticide on tobacco s indicative co co BAT Co LTD MINNESOTA TOBACCO LITIGATION of this trend although tobacco in Germany already comes under the food laws. b) Evternal Prersures The meeting discussed Amcel's smoking material SM and Imperial Developments. The position may be reached within a year or so where Celanese Corporation of America may attempt to exert pressure through the public authorities to get their product incorporated Into cigarettes. In this connection, it was considered that the present arrangements were satisfactory. The present arrangement Is that B.A.T. (Millbank) are in touch with Aricel and .have a relationship which Is 'warm' but limited to supplier and possible consumer. R. & D.E. are testing SM materials an-, Amcel undertake to keep us fully informed and not to disclose publicly without prior consultation. There were reports that Amcel had recently made a 'technological break- through', and if this were the cases both Germany and Canada wished to receive samples through Millbank when these b*=ome available. Germany would also like a s=all quantity of the current product. In the case of Imperial Developments the problems of communication were clarified. Because of the A.M. & r. license to I.T. Co. (G. B. & 1.). Dr. Green undertook to get further clarification with respect to the provision of Information to Bristol of now developments on PCL in C:, and America. c) Externe-1 Resei%rch Pro.-Tremmes It was agreed that such programmes as those at the University of Kentucky and at the Environmental Health Unit at Research Triangle, N.C. (Kotin3 will influence Company research' programmes and may also have other ef!e--ts. For example, the fact that they will of necessity, publish their results should lead to 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 C.. programmes S10 co BAT Co LTD MINNESOTA TOBACCO LITIGATION 6 as for as possible. !n particular. Dr. Griffith thought that B.A.T. had had a most favourable influence on Dr. Stokes of the University of Kentucky during his recent visit to Europe. It was felt that Kotin's work could well provide the occasion for the co-operation of the American Industry at the scientific level. Provided that co-ordination and contact is made through the respective research departments. It was mentioned that these programmes could also be supported by the Industry. perhaps at the expense of contributions to CTR or AMA. d) Pressurns from Co=%etitinn It was reported that both Reynolds and American Tobacco Company had recently greatly Increased their facilities, particularly In the area of product development. It was agreed that this should be taken Into account in planning our own future activities. CDE suggested that pressure in development should not be allowed to erode the research work considered necessary In each laboratory. The exa mple of the I 00 r.-m. cigarette was considered and it was agreed that this development was most undesirable from the viewpoint of smoking and health, although it could offer the possibility of introducing very long filters. S. General Ob of R. & D. The following general objectives were defined following a discussion: 1) To insure the continuation of the industry and the prosperity of the company within the industry. The insurance aspect of research at this time Is particularly important. 2) To provide a technological basis for sustaining and Increasin7- the profits of the company, both long and short-range. 31 To carry out sorne research work which is felt to be necessary if a satisfactory scientific advisory service Is to be provided. No zittc rno %vas made at this time to delineate specific project objectives, but after general discussion. It was agreed that It is essential for the scientific research and marketing staffs to cooperate closely in their activities. co co ...../7. BAT Co LTD - MINNESOTA TOBACCO LITIGATION I 7 6 Smol-inv aw! He-Ith Mr. Keith and Mr. Pare' were present part of the time. Dr. Griffith was not present. Dr. Runeckles Joined the meeting. It was decided first to discuss the STRICKMAN FILTER. The position regarding Canada, America and Germany was outlined. It was agreed that the most important feature was the commercial attraction offered by the publicity which the filter had received, but there was some Indication that a granular bed filter may be of some importance with respect to taste. This could be particularly so with respect to Virginia cigarettes If an alkaline additive were used which might change the ratio of extractable to non-e---tractable nicotine. The lessons to be learned from the Strickman filter were that: 1) In the examination of new Ideas presented to the industry, companies raust be demonstrably diligent even If the Idea does not appear to be attractive at the time. The meeting was unanimous that in the light of the prevailing circumstances, Louisville had carried out a satisfactory examina- tion of the Strickman filter when It was first offered to them in 1966. 2. Companies should insist on Inventors having some form of patent protection and the presence of witnesses, preferably lcwyors, would be advantageous. 3. It might be possible to mark-et a health-crientated cigarette without prior 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 experience demonstrates the general approach which might be made 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 & difforea types and forms of filter materials. Sir Charles Ellis surveyed the progress of current work In the field of smoking and health. He was of the opinion that big advances hcve been made In bio-assay techniques for smoko co co BAT Co LTD - MINNESOTA TOBACCO LITIGATION condensate paintin-, and that a number of different factors affecting biological activity Pro being revealed and there is some evidence suggesting cigarette wroke nvamy only play a contributory role in carcinogenesis. This leads to the conclusion that if enough well directed effort were to be applied. a cigarc%te could be developed which would be of lower bio-assay activity. while possessing an acceptable taste. The meeting agreed that It would be worthwhile to make such a cigarette with lower -biological zctIvity on mouse skin painting, provided this did not adversely affect the.position with respect to irritation lied certain and other factors. It was recognized that thLs Imp assumptions about the relevance of mouse skin painUng; but It was unlikely this test would be replaced by cheaper, shorter and more meaningful tests for the next few years. A further argument is that such a omouse-skin safe' cigarette would be particularly valuable In public relations. In addition to this biological testing which could be undertaken or sponsored by the Individual companies. It was suggested that each company might well consider sponsoring at least a small pro;ramme of longer-range biological work, the main object of ---hich would be to farnilierize the company scientists with the problems Involved, in order to appreciate better the work currently being carried out in the whole field. The difficulties associated with inhaletion studies were discussed and it was agreed that in the likely event that no satisfactory inhalation test could be found, It would be necessary to issue an intuitive judgment based on cellular biochemical studies. Consideration was then given to modifications which could be made to cigarettes now and In the future. It was agreed that this ct-.uld best be considered at several levels. 1) The Improvement of current brands should be continued by removing from the srnoke, any substances Judged to be harmful or alleged to b-9 harmful. provided consumer acceptance is not adversely affected. 2. The development of lorw T. P. hi.. normal nicotine cige.-cttes should continue. In this connection. the use of filter additives. such as P.E.I. might be helpful since It might render the nicotine more available to the smoker.' 3. The development of a low T. P. M. low nicotine cigarette should be expanded. This raises the question of the level of nicotine required and the C=) consumer study by Bristol can be helpful In determining Co co co BAT Co LTD MINNESOTA TOBACCO LITIGATION this. Mr. Sattorf pointed out th-at there was evidencelhat in Germany per cr pi O. at cigarette consumption inc re a se --I for the lov.-or nicotine brands. It cannot, hv.-.-ever, be assumed that the minimum nicotine acccptr-ble to the smoker Is the optimal level, end some consideration should be given to establishing this. 41 Some cigarettes should be developed which are entirely health-orientated and in which health factors predominate in the design. Such products murt be subject to continual review and will require biological testing. In view of the great effort involved in biological testing of new cigarettes it should only be applied to those %which have &L-eady satisfied the requirements of taste, cost, etc.. and which are, therefore, considered viable commercial peoducts. Health orientated cigarettes ought probably to be shorter rather than longer. S) A further approach could be towerds smohing articles which differ radically from existing cigarettes. for example, those constituted entirely from non-tobacco materials or the ARIEL device, or even a cigarette aimed to be pleasantly non-inhalable. It was noted in passing that the trend towards making civerlets milder and therefore more easily inhalable was undesirable on health grounds. it was suggested that the development of a number of health-OrLentated cigarettes should be undertaken by the member laboratories. It was tentatively agreed by Montreal, Hamburg and Louisville that they would r develop or get approval to develop a cigarette made predominantly of locally produced reconstituted tobacco. R. & D.E. , Southampton are already developing a ciga-ette which will Incorporate all factors, recognisod as important In the context of bio-assay with the ob-active of establishing the mast xi mum reduction in biological aczi%-ity attainable at present. Dr. Falton outlined the present cigarette being examined in Southampton. This was 84 mrn. including 20 n-m. dual filter with P.E.I.. zinc acetate and sodium acetate. A ne I wcre being tested and the tobacco rod is 5V@ Burley 3 0 I'lue cured, both cut at 60 C. P. 1. and 20% stem. The PURI device was discussed and opinion was di%-!dad a a to how far fur-,her development was justified. It was generally felt. hmvever, that some co BAT Co LTD MINNESOTATOBACCOLITIGATION further dovelo;nqent should be undertaken particularly with respect to smoking characteristics and consume., ec-ceptance. A general discussion follovied on basic assumptions which guided thinking in the fteld cf sticking and health. While recognising the importance of psychological factors in smoking and the possibility that some smokers would accept non-nicotine cigaren tes, it was falt that nicotine is Important forth* majority of smokers and that the form of nicotine can be significant. It was also considered that nicotine will be increasingly subject to attack. It vms agreed that there v.-Ill be increasing government involvement in the industry. The meeting concluded that adsorbent filters such as charcoal will play a long-term role in cigarette design. Attention has recently been drawn to the sugar content of flue-cured tobacco as a possible factor In respiratory disease. The meeting noted that fermentation as a means of reducing the sugar content Is being tested in the JANUS programme. The use of catalyses and additives to reduce benzpyrone was discussed, as well as the recent patent by van Julsingha on the addition to cigarettes of non-carcinogenic polycycuc hydrocarbons -.. hich are supposed to transfer to the smoke and function as biological antagonists for carcinogenic hydrocarbons produced by pyrolysis. The preli=izmry and tentative indications from results am" Harrogate suggesting that potassium compounds enhanced carcinogenicity were discussed in the context of tho St. Paull process-and Dr. Green suggested that these considerations shouid be borne in rn In future product development work, particularly in cnnnection a health-orientated cigarette. The evidence, however, is not strong enough to suggest that the existing St. Pauli treatament should be changed at this time. It was suggested that it is likely that in the future. some attention may have to be given to the manufacturing process with regard to ,microbiological control. Regardless of the outcome of current Investigations in the fie!d of smoking and health vrhich are died at assessing the im-'=@.arce of micro-biological contamination. In the present political clirmte said with increasing government Involve- Mont, sooner or later tobacco manufacturers may have to conform to standards similar to those in the food end drug Industries. It was agrecd that this is a serious possibility and that members will give this m@ttcr full consideration and draw It to the attention of their managements if appropriate. The situation ir. G3=any regarding the stringent regulations for pesticide residues an tobccco was explained and discussed. it was agreed that rne=-bers, wculd endeavour to obtain information co co C=> BAT Co LTD - MINNESOTA TOBACCO LITIGATION relating to the minimum application requirements of pesticides for Insect control and to determine whether pesticides on the prohibited list could be replaced by acceptable substitutes. Such information, if available would be sent to Millbank for Hamburg. CU Cx:) BAT Co LTD MINN ACCO LITIGATION 12 7. Product Dcovcloor-@,nl. Dr. Runecklos was present. Mr. Baldwin and Dr. Griffith were present part t@ -le). Discussion on this subject was limited to the development of new brands of conventional cigarettes. and the role of R. &. D. in this activity, particularly in Germany and Canada'was described. It was concluded that there Is no easy to product development. but that It is essential to have the continual involvement of marketing, scientific and loaf personnel even before the product concept was developed. The contribution off laboratory work to product development Is. of necessity, somewhat limited, and systematic human smoking tests provide the predominant technique. Scientific departments have a major role in the latter work. Current laboratory tests which are considered of value are tests for nicotine in the tobacco and the smoke, sugar content In the tobacco and total particulate matter in smoke. It was agreed, however, that attempts should be made to find out whether measurement of total vapour phase and/or its pH for example. could prove useful and to extend. if possible, the application V& of extractable nicotine measurements. With regard to the possible extension of the Imboratory contribution, Sir Charles Ellis suggested some consideration should be given to a physical measurement relattig to the nicotine and the smoke aerosol and Dr. Seehafer described an Interesting empirical test (CAMVER) which is still under study In Hamburg. It was agreed that In the long run, a detailed knowledge of how smokers s-noke (Puff pro"lle, frequency volume etc.) and how behavioural patterns alter, could be of great value in product developmant. It is possible that if such a study were undertaken, the mark-et saCment target could be identified with much more certainty and the pre-market smoking evaluations could then be made by panel smokers corresponding to that segmcrt. Such knowledge, of course. Is primarily of importance in the smoking and health field, since it may validate the susceptible minority hypothesis. The first step is to develop the techniques required to carry out such a study and the meeting agreed that this ought to be done. 8. Proc2r!urol @, Tr, a! Vi s! t s After discussion. it was agreed that visits by research staff to other laboratories within% the group are essential !or collabomtion, but , they are also necessary to e=ble the research staff to do their cwn vork proparly. It was also suC.;;asred that in addition. naeti=;s at the level co co M-) BAT Co LTD MINNESOTA TOBACCO LITIGATION 13 of the present one, there could be grea: value in joint meetings at bench level. b) Revorts T'he present system of report is satisfactory to all members. but it was generally agreed that there was insufficient feedbLch to the originating laboratories. One point requiring attention was inadequate reference to earlier work. c) IMOTMC-tion Retrieval Dr. Griffith reviewed the new systems being developed and suggested that a system such as this should be considered for the group. The need for compatabiUty means that the group research requirements for information retrieval should be looked at as a whole, by someone who is a scientist and has experience with computers and dr-ta processing. Dr. Green agreed to investigate the possibility of laitiating this au.-Vey. d) Patents The current practice In patent filing and renewal within the group was reviewed. It was felt that although particularly In Canada. machinery patients had been profitable. on balance too =uch emphasis in the past had been placed on process and machinery patents. In future, an attempt will be made to put much mor& amphasis on product patents. e) Stere-ardisEtion It was agreed that where feasible. group standards should be adopted. but the local conditions for most companies In practice demand the adoption of different standards. It was *rnpbazisod that for any smoke measurement, the number of cigarettes should be determined by the statistical significance sought. With the alm of comparing relativa results from the paramoeciurn bio-assay test. Hamburg agreed to circulate samples of three typos of cigarette to Louisville, Mom-r-al, Sydney and Southr mpton. f) Divcnr i f i cz. tinn It was agreed that diversificction does affect t;-.e morale of research staff. It was also felt that in sorne conmpazucs there is particular expe rt avail-ble which could be helpful In diversification exercises but which Is at present not used. Vi'.0re laboratory staff had been used in divarsificrtion co co BAT Co LTD MINNESOTA TOBACCO LITIGATION 14 this wzs felt in general to have enriched their experience rand made them better In the tobacco work. Whe re R. & D. staff can make a contribution it is highly desirable they should do so, provided mat in the long run, the approved proor;ar-wie of work on tobacco and Smoke is not eroded. g) Corprta A di =ussion was held on d*velopments within %..oresta and the question was raised an the advisability of other companies joining. Dr. Greon said that in general. this wets contrary to present B.A.T. policy. The German company 3 a member for very special reascrns. The German company will keep the group Informed of developments and will supply copies of the Bulletin for circulation to Louisville. Montreal, Sydney and Southampton. 9. R e c c" 1,tsurn--t!cn!; The follo--ving were agreed: Research can be profitable although we are in an industry where new products generally cannot be attributable directly to research. 21 Nicotine is Important and there Is probably a i-',r.imum le-.el of nicotine to which for many people the habituated effects of smoking are attributable. The form. of nicotine probably affects the rate of absorption by %he smoker. 3) Government involvon. ant in the tobacco industry will become greater in the future. 4) The smoking and health V. oblam is amenable to a research solution. This Is a significant change in thinking end is a direct result. of research. S) Product characteristics are important In maintaining sales and for Improving the market. co 6.11. 67. co C= BAT Co LTD MINN A TOBACCO LITIGATION