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;~i? : ~!i~i :z i ~: • ::i.¸ BRITISH AMERICAN TOBACCO Copy Request Form Request Number: 22 Organization: Physicians for a smoke free Canada Request Details Request Date: ....... ~....(~....~..~ ............................. ........ .... File Number: .... ..~...~...~....(~.. ..... Box Number: ..... ..~....~...~. ...... Page Range: First Page L f Requested By: (Print Name)....~~~. ....................... Details below will be filled in by Depository Staff Only II Copy Details Copied By: ..~~...~..~ ...................... ... . . . Date: ....~..Z../..~./~.. .............. Tim e: ./~..'.(.~..... .......... Copy Checked By: ................................... . • • • B • • eeo• B• • •o* ** • • e• Date: ........ Time: ...................... .. ..... •.•. ••oil• aeo• le oI• *o• .•• • e• ., III Delivery Details Checked By: Date: .............. • l•o•..oe.•o. • • •o••••t,•• • u•.••. • e•• • •e ~e• Sent By: ..................... Date: ..... • •.=•.l••••e•••••••• • o••o=••••e•o re•. BATCo document for PFSFC 1 March 1999

5th September 1974 k I SJG :~,~ t " ..~Z~'1 IW L :' ;:[,-F ii~,i ' . . • /= ~OTS ON Th~CU~R~T STATUS OF SUBSTITUT~S /UND POLICY Current trends in tobacco prices gives added incentive tO exploring further use of reconstituted tobacco and non-tobacco substitutes. B.A.T. policy on the use of substitutes has been stated since 1952 as follows: 'K~e will not use substitutes unless there is a demonstrable advantage on. heal~h grounds". Since that time ouu: policy h~s been modified in some respects In/gely by the interpretation of what we mea~ by "demonstrahl@ advantage". The present position is that we regard ~ material as having & demonstrable advantage if it gives cigarettes with lower tar and lower nicotine and with carbon monoxid~ no higher and shows no increase in biologic~l activity. The Hunter Committee Guidelines b~ve now helped us to clarify what we mean by biological activity: this should cover an examinatio~ of the chemistry of smoke inclu~ding materia!s such as benzpyrene, nitrosamines, hydrogencyanide, etc., it should cover tests for tumorigenicity both by skin painting and by inhalation~ i% should also involve some general inhalation toxicology. Hunter~ of course, is developing his Guidelines further to include clinical and other human studies. B.A.T. could go fur~er tha~Hunter in one respect= we could take cognizance of the initiation/promotion hypothesis and aim to get both a reduction in total tumorigenici±y and im promotion activity~ .. A list of substitutes and their present status is attached. To my knowlede~ only two of these axe likely ~t present to show a demonstrable advantage on health groun~ that would s&tisfy us : these are CYTREL and N~. ..- ....... .. . . PreSumably we would only use tobacco substitutes if they prove to be profitable in the broadest sense~ i.e. acceptable to the consumer, acceptable to the cigarette manufac%n~rer .. available at the right price~ etc. One other condition,'of coursep is that they would not contravene the law in the market for which the use is intended. Before they are used in any. particular market careful consideration %vould also have to be given %o any change in the legal position with respect to cons%~erso " In my vi~ the fact that tobacco substitutes have bee_n accepted for sale by the German Federal Health Ministry does not necessarily constitute a demonstrable advantage on health grounds or provide a basis fo~ use in any other country, Th~ tests carried out under the German la~ by Professor Kr~le consists only of simple pyrolysis tests and benzpyrene determin- ation~ on this basis BATFLAK~ CYTREL and N~4 hav~ all been cleared. Equally although the Hunter Guidelines are v~ry much more extensi~J~ it does not follow that clearance by Hunter would be satisf~c%ozy--~ for clearance either by B.A.T. or for use in another country. C~ Contd. BATCo document for PFSFC 1 March 1999

w 2 (~ This last raises important questions. If - as lot pEomotion - ~,e regard Hunter Guidelines as inadequate should we do our utmost to get the C~idelines enlarged or should we b~. grateful for small mercies. Should we insist on more stringent requirements to satisfy B.A.T. than are required to satisfy Hunter, or :foz that matter Kr~le'~ In my view we should get : the best legal advice ~e can with regard to potential maxkets and our responsibilities as manufacturers. This advice will almost certainly require us to act responsibly and it may be necessary to get independent medical advice. Suggested actions are as f'ollows=- I. "We should get legal advice on our posiT/on if we use substitutes in the UniTed ICingdomo Perhaps similarly opinions could be sought in U.S.A., Canada and Australia. 2o v.~'e have promised to propose to American Celanese 'a clra.f~: agreement for the purchase of CYT~EL. This would, if accepted, commit us to buying a given quantity of CYIREL contingent upon CYTREL remaining in substantial quantities in cigarette~ on sale in the U.K. This would cover both consumer acceptance and any revision in }~nter requirements or reversal after testing on humans, - : . . • .~ -~. ~. ".. :..;'; 3. We should aim %o get ~ similar understanding with IDL for NSM. 4. We should.continue to press o= with BATFL/~ development . and a propdsal wil-i be ~ut "CO %he Tobacco Board in this respect on the 20th September~ ...... • . = ° . . . . . s. we sh ld approach to Courta.ias to lore the possibility of some. co-operation or a phased Joint venture.. ' The ~ attraction here is that it .is likely that they ¢oul'd quickly engage in large scale production. 6. We should diligently inform ourselves ~yi%h respect to the other materials, particularly Ecusta which is being %es£ed by the ~|.C°I. in ~merica. .. 7. We will make a point of examining the Bayer material when it appears in Reemtsma's cigarettes and thus becomes available to us, at least for la'noratory work. 8. We should continue %h~ develooment o~ r~consti~ut~d substitutes with lower biological activity. Enc : S, J. GREEN CD CD O~ • ..U BATCo document for PFSFC 1 March 1999

~... -° APPENDI:( I t BATFLAKK N .S.M. CYTRHL ECUSTA COURTAULDS • . . .. BAYER DUPONT S~L%W PRODUCT SUI'ION RESEAR~"q B.A.T. product based on chalk and sodium carboxymethyl cellulose. Approaching decision stage for semi-commerci~l plant. Weak but useful patent position. Probablyg~ per lb. Product of Imperial Developments Ltd. Full scale 20 - 30 million ibs/year plant under construction. "-/ Partially oxidisedcellulose. Useful p~tent protection. Expensive - probably over ~ 1/lb. Product of American Celanese Corporation. Full scale lOmillion Ibs/yeax plant under construction. Inorganic additives with cellulose bonder - probably carboxymethyl cellulose. Useful patent protection - not imprzgnable. Price at present values about 75 ~/Ib. Product of Ecusta. Believed at pilot plant scale but probably no problem in production as is essentially cellulose. No patents. Probably 50 ~ /lb. NO biological claims but under test by H.C.I. No public information. Probably viscose. No patents known. Price - not to be offered for sale but cost is probably around 60 ~ /lb. "' :?Could be produced readily. . . . Ho information but will be on test in Germany and samples can then be examined. Almost certainly cellulose based. ".'" Batflake type product based on aluminium compounds. Laboratory stage. Vegetable reconstitution. No biologic~l information. ~y be on sale in U.S.A. in 1974. No knowledge Presumed dead - was reconstituted vegetable waste but effectively flavoured. Turned down by IDL, B&W and BAT. Patented. Cellulose based. • s" C~ C~ k~D •t~4 BATCo document for PFSFC 1 March 1999

SJG :NW 5th August 1974 U.K.R.& D. PROGRAMME 1974/75 The planning operations undertaken by the Tobacco Board have implications for the Group R & D programme. The Study on Security and Economy of Materials does not throw up a~yparticular project but suggests a general R & D contribution in utilisation of materials, consideration of alternative materials, improvement of machine efficiencies - all of which are reflected in the general R & D programmes around the Group. A need for technological forecasting is also shown and this could readily be provided by R & D. Here we have experience in forecasting as a necessary part of all important projects but at present we have no identifiable group with this specific responsibility. The Study on Diversification indicates no specific task for R & D but it is worth noting that Group R & D has working in the tobacco area over 200 technical graduates recruited to a considerable extent from other industries and these would be used occasionally as a source of advice on detailed expertise at virtually no cost. The Study on Leaf underlines the need for R & D to provide a source of information and guidance in product development information and experimental methodology and a general training function. From this study an R & D project aimed at improving leaf blending techniques would seem to be needed. R & D advice and occasionally experimentation is currently provided on disinfestaticn, on chemical residues, agronomy and leaf processing. The main impact on the R & D programme, however, as might be expected, comes from the Studies on Market Expans- ion and on Smoking and Health. The Market study indicates that R & D should aim generally to provide as much technical understanding and support as possible to achieve the marketing objectives and that this will be related to product attributes and consumer preference. In particular the aim to produce cigarettes with health re-assurance and "normal" taste emerges and one very clear objective "to seek out cigarette character- istics which will significantly affect consumer choice". In the Smoking and Health field the development of new smoking material, new products, modified designs and reconstitution of tobacco, as well as reduction of carbon monoxide, perceived benefits of smoking, special filters, alternatives to nicotine and the study of the susceptible sub-group hypothesis reflect the close association of the current R & D programme with thinking on Smoking and Health over the years. c~ Contd C~ BATCo document for PFSFC 1 March 1999

-2- Some of the ideas above (e.g. susceptible sub-group) are covered by Industry research co-operation (e.g.T.R.C.). Others are covered by Group R & D other than at Southampton (e.g. agronomy studies and tobacco development) but in fact everything thrown up by the Planning Studies is already in Group R & D programmes - that is not to say that the current emphasis is necessarily correct, and it is intended to raise some of these questions at the next Group research conference. For example, "alternatives to nicotine" is a project at present costing less than£2,000 p.a. and this may be considered inadequate in the light of the Smoking and Health Study and some recent developments. The purpose of this note, however, is to outline the current U.K.R.& D. programme (other than T.R.C.) in order to get approval by the Tobacco Division Board. It is presented as a basis for discussion which it is suggested should be limited to objectives and expenditure; how projects are designed to meet these objectives should, as far as possible, be left to the professional expertise of the R & D staff. A considerable part of U.K.R.& D. work is concerned with objectives that are already clearly stated and defined by parties paying for it, e.g.P.D.L, work, flavour manufacture, par~ of machinery development, instrument manufacture. Such work amounts to roughly f~O0,O00 p.a. which is recovered - the remaining R & D work amounts to roughly £1.5 M p.a. and covers the following: (I) Smoking Products Research £390,000 (2) Life Sciences £480,000 (3) New SmokimgMaterials £ 80,000 (4) Process and Engineering Development .£290,000 (5) Project PRT-71 and a number of small £300,000 contract research items, etc. (I) SMOKING PRODUCTS RESEARCH Our research programme is largely aimed at cigarettes which are preferred by smokers either generally or in significant special cases. The part played by the chemical and physical research projects is obvious and has been described on previous occasions. Projects involving human smokers, however, are relatively new and some description maybe welcomed. Under Project WHEAT, about 1,5OO smokers have been interviewed and their answers to the McKennell questionnaire examined by factor analysis. There is gratifyingly good agreement between the factors we have isolated and those obtained by McKennell in his studies. Cluster analysis has yielded a picture which, although differing in some points of detail, is again similar to that of McKenmell. The Agency report on the preference responses of the 1,500 smokers to four experimental cigarettes, which differ in the level of nicotine in the smoke, will be available in late September. Assuming that the results C on~cd .c~ BATCo document for PFSFC 1 March 1999

-3- show a useful pattern it is intended to follow up this work by an examination of the responses to variations in "taste" factors. It is possible that market segmentation may be established in terms of motivation profiles. To look further ahead, it may well be possible to examine (under Project OSGOOD, which is discussed later) whether a refined version of the approach can be applied in an overseas market. During the current year there has been fruitful collaboration with Dr.C.D.Binnie (St.Bartholomew's Hospital) in the study of EEGs of smokers and non- smokers. The results from an initial survey involving several hundred people will be available in late 1975 and should throw light on the claimed association between EEG response and chronic ("life-time") smoking. The acute effects of smoking have been examined in a study in G.R & D.C. Southampton using matched groups of smokers and non-smokers. The EEGs were measured by a team from St.Bartholomew's Hospital, with part- icular attention paid to the Contingent Negative Variation (CNV). The personalities of the subjects were mapped by a consultant psychologist (Mr.M.Oldman) and the way in which the cigarettes were smoked was recorded on our puff-analyser. The computation and detailed analysis of the results will not be available until late 1974, but visual inspection indicates that smoking a cigarette frequently causes a change in the CNV. The experiment involved a certain amount of stress for the subjects, and we know from the puff- analyser that some individuals changed very markedly the way in which they smoked. Since we have chosen not to have access to the personality data, it is difficult to examine the extent to which personality influences smoking behaviour or choice of cigarette and we propose, therefore, in 1974/75 to recruit small "smoking behaviour" panels from outside B.A.T. The generation of "~-waves" in the brain, might be associated with the elusive factor of "Satisfaction" in smoking and this will be studied more intensively on R & D volunteers. It is planned to complete Project KEW - an attempt to relate the terms used by consumers in describingperceived differences with the terms in the WOODROSE vocabulary - and to examine the importance of variability in draw resistance as a parameter which influences consumer response. Work on the control of the puff-by-puff composition of smoke will continue in 1974/75, and consumer response to different smoke "profiles" will be examine~. Initially, internal panels will be used, but if encouraging results are obtained, external panels maybe required towards the end of 1975. Contd. c~ BATCo document for PFSFC 1 March 1999

-4- (2) A specialised internal panel will continue to be used for the subjective assessment of side-stream smoke, whilst the more traditional WOODROSE panels will extend the current work on the link between chemical composition of smoke and aspects of taste and flavour. Significant progress has been made during the current year and further application of oil-water partition, mass spectrometry and, probably, capillary column gas chromatography is planned. This work, together with a renewed attack via amino-acid composition on the recurring problem of blend analysis and a study of the effects of blending on taste factors, will strengthen our input into the technical aspects of product development. The construction of the Environmental Chamber should be completed in October, and during q97~/75 we will be able to examine whether climatic conditions affect taste responses. We know from previous work that climatic conditions affect smoke composition, but there is no information about human response. Project OSGOOD is a product development project not funded by R & D. The initial phase is a detailed study of the technical aspects of the cigarettes avail- able on the Dutch market. We plan to follow this with a research project aimed to test some hypotheses from R & D's smoking product research programme in another market. Clearly all the above projects depend on continuing our advances in understanding the chemistry and physics of smoke and developing sophisticated techniques aimed towards the design of cigarettes. Specifically combustion studies aimed to control carbon monoxide, the effect of aerosol physics on taste, the contribution of paper formation, the design of filters, the effort of microbiological flora and the effect of processes on the product. Alternative sources of nicotine and alternatives to nicotine will be studied. LIFE SCIENCES RESEARCH The Life Sciences Research programme is designed to put B.A.T. in a position to understand the relevance and importance of advances made anywhere in this field and to provide facilities to develop and apply biological tests to our products in order to guide general product development, investment, or the development of specific products. This programme must give us the facility to respond to the Hunter Committee or any other external constraints on our operations in this respect. Contd. o~ ~., ~O BATCo document for PFSFC 1 March 1999

There is currently a shortage of facilities for routine inhalation bioassay and it maybe sensible during the year, to make proposals for the expansion of such facilities in the U.K. One proposal being considered is the provision of a loan to Wickham Research Ltd. Until a year ago, the contract research was undertaken at Battelle, Frankfurt. Following the currency revaluation, much of the new extra-mural research has been set up at Life Science Research Limited and Wickham Research Laboratories Limited in the U.K. The cost of the Battelle contract forcast at £360,OO0 for 1973/7@ has been reduced to E200,O00 for 197@/75 and costs at Battelle will continue to decrease. The work in progress and envisaged at these centres is outlined below. BATTELLE: Current studies include both mouse skin painting and inhalation. One rat inhalation project, designed to examine the possibility of enhancing tumour response in the larynx, using a Vitamin A deficient diet, will be completed during the year. In a second inhalation study just started, the effect of smoke from PRT cigarettes is being compared with am all- tobacco control. LIFE SCIENCE RESEARCH LTD: The current long-term mouse skin painting experiment, transferred from Battelle, is designed to examine the effect of PRT process variables; it will continue until 1977 although our predictive techniques will probably enable us to form useful judgments in 1975. Allowance is made for a further long-term skin painting experiment, This could be on (a) the effect of nicotime level in tobacco, (b) the best method of utilising stem, or (c) the new style of experiment designed to examine the effect of switching from a standard cigarette to NSII/CYTREL/PRT/BATFLAKE. A short-term sebaceous gland test is being developed and it is expected that this will be used on a routine basis. WICKHAM RESEARCH LABORATORIES LTD: The current evidence imdicates that tobacco smoke condensate is only a weak carcinogen and that the biological activity is largely related to its promotion effect. A six-month promotion study (mouse skin painting) has just started. It is anticipated that a new promotion study will be initiated to examine the effect of foamed BATFLAKE or the effect of tobacco variables on FRT. It may be that we shall propose the establishment of inhalation toxicology facilities at Wickham. OTHER EXTRA-MURAL STUDIES (BIBRA): The major study on the toxicity of coumarin in the baboon will continue throughout the Budget year. The results will be published and it is hoped to obtain uniform use or non-use of this additive. Special toxicity studies (Menthol) are being undertaken at BIBRA and at Life Science Research Ltd. at the request of Brown& Williamson. The costs will be recovered. Contd. cr~ oo BATCo document for PFSFC 1 March 1999

-6- (3) CONDENSATE PRODUCTION: As an adjunct to the mouse skin painting studies, transferred from Battelle during the year, a condensate production unit has been set up at Southampton. This will continue during the current year and further expansion of facilities and staff is foreseen to meet the increased demand for condensates from the new studies planned. The new Life Sciences Laboratory at Southampton will probably be operating in the first part of 1975 but by renting accommodation at Wickham the work has been progressing for some months. The primary objective is to establish quantitative methods of undertaking and assessing inhalation studies. This aim is reinforced by the draft Hunter Committee guidelines for both inhalation and teratological studies. In addition, it is hoped to develop short term in vivo inhalation tests, e.g. tobacco smoke on alveol-~ macrophages. Other short term assays, such as Nitro Hethane Fraction Index test, will continue to be used. Studies will be undertaken to assess various smoke inhalation systems. The assessment will include (a) the effect of smoke and smoke concentration on the respiratory pattern of various species, (b) the measurement of smoke concentration in terms of gas and particulate phase indices, and (c) the measurement of the dose of smoke reaching target organs in the respiratory system. It is planned to recruit for the Life Sciences section twelve additional members of staff, including two graduates, a senior animal technician, a number of Junior animal technicians and laboratory assistants. The aim remains to have only a research facility at Southampton and to contract out all routine work on animals. NEW SMOKING MATERIALS The specific objectives of this work are: (a) The development of materials with controlled smoke properties. (b) The economic utilisation of waste tobacco. PRT m Participation in the PRT-71 project will continue through 197@/75. R & D facilities will be used to study the modification of product attributes; in particular, smoke deliveries and subjective properties. Process and product variables will also be monitored. A study group will be established in Brazil to examine the feasibility of PRT, and experiments will produce and evaluate a suitable product. c~ Contd. c~ -~ ~o BATCo document for PFSFC 1 March 1999