GIV ;Bj L 1983 TO Dr. L.C.F. Rl1ack=an, I FRam Dr. T. Hirji. FILE C' .. Director, PASS .............. Millbank. COPY REF TH/JJ/ CATE 11th July, 198 .. ........ ............... .............. I comments on "Whenlcw tar cigarettes yield hich tar : Cigarette Ventilation hole 1:l-:c,-;na and its detecticr." (A paper by Lcrtbar~-c, --avis and Pr-ze, Addictive Behaviours, 1963, Vol. 8, pp. 67 - 6:. I have had a disz-~:ssiCn with Rob Ferris on the above paper and our comments are as foll_zws. a) T%e first paragrac':: states "4proximately 50% of low tar smoke:s, however, to _-_==k,_n; or partially blocking these holes Admitting to sz=ething and act-_,ally doing it are quite f observed data from different things. line analysls o. ~ Project SINCS (M:-:-:: ;:oject) shows a=r=ximately 85% of total puffing behaviour _*s ---.blc=ked. in t-his project we also have the same smcker's es:i=ates of the ancunt of blocking they do. Although the results are not yet available, it will certainly be in excess of the act---a! observed behaviour. b) Sample sizes would a;=ear to be ri-4-cuc-,;s1y sm-all for generalisation. - a figure of 8 Is 7:entioned for P~ase 1 and no indication is civen for Phase I: it cannot he mcre than 30. Project SINCS Is tesed on 113 sublects. c) The statement cn ;:a~e 68 - "An average of 68% of ventilation holes were b1ccked" as deterrained !:Y f.ngerti;s coated with fingerprint ink Is a -.et~ingless clain. Agreed that the experiment indicates that at scme stace of cigarette life the holes would be partially blocked but ;I,- does not follow that the c1garettes would ~e held at all or will he held in "partially blocking" position during puffing and it is at this stage the blocking will matter. d) The observation of b-ocking incidence increasing in last puffs is broadly true. Pr~ect SI140S suggests that the percentage of C) "D partial blocking increases slightly on terminal puff viz 71% C=> L4 U') unblocked. CD CD Suggestion that the incidence o. blocking might be greater thwan (_P4 Kozlowski estimates Is ironic since it is made on the basis that CN co rN; BATCo document for Legal Services : Health Canada 20 October 1999 W 10pn=1 rim some of the smokers who had reported nct blocking the holes were observed by Lor_!;ardo et al to bre blocking the ventilation holes. Project 5:NOS experience de=cnstrates that direct observation of p-uffinq would be a most unreliable rDeans of detecting presence of any b-ocking. it is on-y during close inspection of video recordings ~_n slow motion that it becomes clear that many apparently blocked puffs are infact untiocked. f, In conclusion, our view is that the best part of the paper is its advocacy for systematic observational researc'n. Project SINOS (to be reviewed at this mznths ~TX' =eetinq) is exactly such a study. Since this st-udy invelvet Myra Thomas from University College, Cardiff it would bea very tempting to cons--der publication of our results by the third party in a journal such as the Addictive ae!,,avicurs. The benefit of such a publication would be to help relieve some of the pressure on the industry which stems from t~e misconceived nation of s-gnificant abuse of the ventilation s-vste=. However, aca`ns~ this we need to weich ver: y carefully the e"'ect such a pu!:'-ication would have on. ff- --he Group activities involving products with AC."RON filter. For instance, since all ventilated products are under scrutiny, aiv prooc-sals which may be ultimately ai.--e-a at ACTRON products need to be validated on ccnventiona- :,r=d%:cts. This b,_ys us quite sicni-icant amount 04~ t4 me. Hcwe7er, if the ccnventicna_ ;:oducts were no lancer uncer question th~-n we woul~- be ab-'e to divert t-e at:tac-s as readily. S.: Finally, for at= cwn Croup irfcr=ation, : feel it wculd be useful, if feas_!:;_'e, to fol_'c&w-,.;= the S-_~;CS st%;dy wt_th same I ce__very increases smoking machine e%zeri=ents tz~ see what sort a--' ' ' ' were irzlied bv =:,.e t-~-oe and levels of !~_,-ckinc otser%red. s will help out int= perspective the increase fr~:= to 23mg L quoted by K--z'owsx:. 'n his earlier papers. -9 b- 1~"5e7 % ce CD Mr. R.P. Ferris. Co CD CD r~J C'\ BATCo document for Legal Services : Health Canada 20 October 1999 lot 14 JUL ACK RESTRICTED MILLBANK PRODUCT DEVELOPNIENT COMMITTEE Minutes of Meeting held on Friday, lst July, 1977 at G.R. & D.C. Southampton. Present: Messrs. P. Shee*hy C. G. Bowra 0 S.J. Green R. St. ~7. Walmisl-~y P. L. Short F. Haslam By Invitation: D. G. Felton N. E. Willis Matters Arising From Pre%~ious M~nutes ACTION a) Paper, Plug%vrap and TippinL, Porosities Dr. Haslarn reported that in!or-nation on new developments in this field is now being passed to Wiggins Teapc on a regular basis. In addition, technical discu ssions ha ve recently been held with de Mauduit and Bollort- aud the quality of Pirahy cigarette tissue reviewed with Wiggins Teape and Pirahy personnel. b) Flavour Manufacture Dr. Green described the plans for the future devulopment. of the flavour manufacturing unit in Southampton. Mr. Sheehy asked for steps to be taken to ensure a reasonable understanding existed between Marketing people and those engaged in the development or flavours in order that such develop- inent could move in the desired direction. PLS Ln C:) c) D.-lanulacture uf CigareLtes wit.--. Ventilated Filters ]Ar. hwvrsi :-vp-.)rLed Ui3t iki t!;c Group 4= CD jj4 4.2. -.1 co co .. 0 -Ij N) (-rl co BATCo document for Legal Services : Health Canada 20 October 1999 1, 7 ACTION 13. C-13 V Dr. Green reported on his visit to see the C; 13 plant in Australia. He felt that the installation was soundly engineered, and the plant had been completed on time. Freon losses were markedly higher than had been indicated and he expressed some concern at the technical complexity of the plant and its suitability for operation in less well developed countries. The plant is not suitable for adaptation to the carbon dioxide process. Mr. Sheehy asked that a meeting be set up withReynolds to consider the legal and environmental problems of adopting G-13 more widely in the Group. The suggested date for this meeting is 3~th September. Dr. Haslarn will seek the views o." the Committee on AV who should attend and will make the necessary arrange- ments. FH Mr. Willis will be visiting the Urited States in the near future to examine the D.I.E.T. plant and Mr. Sheehy suggested that it would be advisable for a lawyer to be in attendance during the discussions which would take place. NEW 14. LOW DELIVERY CIGARETTES - SWITZE:RLAND i. Dr. Faslarn informed the meeting, of a low delivery cigarette development from Switzerland, based on a ventilated non-wrapped acetate filter. A progress report will be presented at the nex'. meeting. FH 15. COMPENSATION AP Mr. Wood's note on low delivery c.garettes was considered by the meeting. Mr. Sheehy asked whether, from our knowledge of the ccmpensatorv responses of smokers, cigarette designs could be postulated which took advantage of this information. For example, could a 9 mg. cigarette be designed whic!-1 would make the desired adjustment of smoking pattern easy to the . 7 VV A smoker. CIA 16, DIAMNIONIUM PHOSPHATE In order to clnrify the, value of diammonium, phosphate 14-4 42 co P cc) ~,o co BATCodocurnent for Legal Services : Health Canada 20 October 1999 RE STR ICTE 0 RE SEARCH CONF ERENCE RIO de JANEIRO, BRAZIL 22-26 AUGUST 1983 10 u~, Present: Or C I Ayres Or L C F Blackman Mr p Denton D,r p J Dunn Or M J Hardwick Mr A L Heard Mr E E Kohnhorst Mr R G Nicholls Herm E Rittershaus Ln Dr R,A Sanford CD (-4 Dr F Seehofer Dr C J P de Siqueira CD I 0 co C-0 co %~o rl%-) (--4 I,- C) t-^] L-q BATCo document for Legal Services: Health Canada 20 October 1999 SMOKER :OMPENSATION AND MACHINE TEST PROCEDURES 16. Cc-.:~ensatlon is now attracting the interest of Goyerrizent ar:: medical auth--rities in many parts of the world. -hi s i s bazed on the increasing- number of new studies and, in ;art, by the evidence submitted by the industry to the FTC ~n the Be-:lay investiSation - much of which has already bee!~ cc=iunicated to lovernment authorities in Australia, Selgium, F-4-7and, Holland, Switzerland and the UK. 7. Ths-e is now an urgent need to assess whether there a--a wa-s in which t--2 ind"ustry can either counter the sit.-ation ar-iliternatively turn it into a commercial advanta5e. 18. A -_'rect conseq~=_nce of this growing interest in cc.-,;e-!sation is -..he possibili.:.w tna: the FTC, and other authorities, may ca - for a chance- in tne standard sawking machine tes'. p!-::edure for al' products. If this were simply to Ite a mc:-fication to -,ne existing standard procedure (in:reased pt;-- volume, duration or interval) the effect would oe- to in:-ease deli Yery levets but it would probably have li::Ie effect or Table rankings. A more extre-e pc-esibility i s tnat an entirely new test procedure c:;.*d be :eveloped, ec a biological index or a Herzfeld-ty-,e mu'-_iple deliyer,, index. Ei--.-er move woul: weaken the concept of low tar and -*:.;1d bc-.- confuse and ::once-n the smoker. Operating Compan~es a.-.-.;nd the Group shouid, therefore, do everything possible to :efend and mai -itain the present standard test procz-!ure. Iff, however, the FTC or any other authority takes act4:n Ul to :hange the prc:edure the strategy should then be t: CD st-etch out any d4scussions (both with the authorities an- later at ISO,' until exhaustive studies have estab"shed CD thz-: an alternative procedure is in fact more relevant. co %10 (_~4 L^j BATCo document for Legal Services: Health Canada 20 October 1999 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 such knowledge-,we shall not be An a position to judge what would be best for the industry in the longer term. 21. In the 1977 BAT Smoking Behaviour Conference i.t was openly stated (and later published) that, while the standard machine delivertes were based or arbitrary machine settings, there is experi7~ental evidence to show that the smoke uptake of 'the aterage 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 encz-,raging a joint approach if a new tes: method is deman:ed. 22. In such dialo9z;e, the opportunity should be taken t-. inform authorities that contrary to the widely held belief t'hat the average s-moker :ets more smo~e in the later puffs, s.-,okers in fact tend t: do the opposite. Thus the smoke delivery profile of successive puffs dilfers from that of a standard smoking machine, which produces an increasing amoun,, of smoke in the la-.er puffs. Much of this information has come from more recent ITL results on puff-by-puff analysis using a 4-part -.uplicator used in a modified mode. timaely and relevant that ITL 2---. It was thought , :articullarly . should attempt to infl~;ence the protocol and techniques to be used by Or Rickert (Labstat, Ontario) in his pro;osed major compensation study on 3000 Canadian smokers. 24. Whatever the outcome of the various public debates on compensation an.' test procedures, we must aim to use our knowledge to develop products that give improved s-moker c::) CD satisfaction. The concept of 's.-noke elasticity' can be 110 C-0 co expected to plav an Important role. co %.0 Jt:. 9 BATCo document for Legal Services : Health Canada 20 October 1999