SECRET
Sqw,latorv Issues and the r,"-'s Tobacco R-irp--
C/
CONTRNTS r \ 1^1
Ile
Intro&=tian
............................................ page
I
Dire&- Regulatory Issues
................................ page 1
Regulatory Authorities
................................. Page 2
Regulatory Regiiremats and Product Inniovatim
.......... Page 3
BAT and Regulatory Issues
............................... Page 7
R----,.Iitdcns for action within BAT Q=%
............. page 9
ticns for o=rdimtim of Policy (External) ... Page
ii
AppaxliX 1 Indirect EnV:L,..-d.&1 Iss;
) Available in the UK
An-,dJx 2 Possible Scientific Wmlcpmm*z )
AppemUx 3 Rmpirments of Regulatory Authorities
Appe.-dix 4 Odsting Regulatory Procedures in
Germany
(-,n
C)
("i
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FMTTATCFV TcMJM AND qTM GFCUPIS 70BACCO BUSTMVIIM
Introduction
In the 1990's a probable scenario is that the tres
of the 1980's, tending to
favour the consLoer at the expense of the
producer, will continue and may well
accelerate as other preo=q-t such as East/West
tensions diminish. This
will lead to increasingly st:ringent regulationis
cm*=Uing const-er prol=ts,
partly as a result of the activities of INgreen"
and bealLh -- ~ Ict pressure
groups, although GC7verrmants are generally
reluctant to legislate'for the
e)LL-L.. views of such gr-ps, even for tobacco.
BMW=, it seems likely that
the tobacco inIztry will cmitinuie to be at the
fu-ia-& of oxh regulatory
activity as is enacted and even in the absence of
zpmr4fl- legislation
cw-g~ will, require prolucts that are seen to nake
some cmzxmicm to
these ism . Examples include lead free petrol,
d-ffi-inated coffee, and
from the tobacco industry ultra-l- tar cig-ttes,
and pesticidL-ftee tobacco
etc.) .
in terms of the cigarette market x to these ism
will be of crucial
impartance. Great q:t= =uties will. arise for the
am f-t-ws vft best
anticipate and respond to the constraints imposed
in the market place,
although in addition to X-IUct irlr--t3.- support
may be r---y for
existing brands.
mle- controversy over BArMAY arose principally frm
a Philip Morris view that
it was an immative and successful contender in the
ultra low tar sepmTt,
which would increasingly itportant as regulatoory
pressure forced tar
ceilings daAwar~ds-
This paper seeks to identify the regulatory issues
which will directly impact
on the Grow,s tobacco bush-jess in the next ten
years, and aoncluaes with
prcp~,--I- for their management.
In &3dition there are other aspects of Regulatory
Ism to be considered.
7 he more general a of an. world win have
inportant inplicatians In the 1990s for all
iTzIUstries. Plor eoozple, the
Zj-& to XMdLIM ni-irns of f1l cocarbans; (CPC's)
has already bad direct
effects within the BAT Group i.e. the to
discontinue the G-13
expansion process. This area wiU be considered in
Appendix 1.
Finally, them my be other events or scientific
developments which my or
may rx7t be takEn up by regulators, and which iray
not be directly related to
the industry, but which could have indirect
effects and may influence total
sales. By their nature, such events (e.g. a
dramatic increase in the
incidence of AMS or a major scientific
breakthrough undermining =Tent
attitudes to the cause of di--) am both difficalt
to forecast and almost
inpossible to azytrol. As it is debatable wt~ether
they strictly fall within
the scope of regulatory issues they are briefly
considered in Apperdix 2.
Direct Recrilatorv Tssues (Wsfira and k7ticiDated)
Ln
11 he following topics am considered to faLU
within this area, all of which C)
relate to prcduct, development. %,
cr\
1. (a) ceilings for deliveries of individual smoke
components in mairw-_,-pm
smoke and associated methods for measuring
delivery (Tar, nicotine,
czll-= morimcide and sxh other smoke components
which may be
ide.-tified by regulatory authorities).
BATCo document for Province of British Columbia 25
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(b) 0eilings for deliveries of irdividual smo~m in
sidestream --k (again tar, nicotine etc.).
2. Evaluation of novel IALuais~ses uhich may be
used in future
cigarettes against regulatory reqlir~s and
consideratians of
reasonable safety.
3. Further evaluation of additives, agruct-ir-l-,
or any other &AMicaLl
added to t at any stage Prior to sale.
4. cigarettes with low him pLyjAdaity.
5. Biological tests for measuring -taa- qjality.
6. Bi(I-i-I tests for MaMM-ing interactions With
the
swiroment (e.g. meastmement of Ma adducts).
Underlying these sper- i fi r regulatory natters
are tbe general smaking and
health issues of which the folluding are those -
St trequently raised by
regulators:
(a) Associations between smoking or environmental
taba and
disease.
(b) c-pensation.
(c) Addiction.
pa=, I atorv Authrmities
In most ca the ulti-te regulatory authority is the
Gover~~ of the
country enacting legislati- which regulates the
industry. Ha-wer, there are
frequently advisory bodies who initiate proposed
legislation and who may be
prepared to consular the views of the industry at
various stages
before the legislation is fix- I i-i - Direct
cmtact with politicians is also
possible. In some cases the industry is xvgulated
on a voluntary basis with
some opportunity for modifying the pruposed basis
of the notably in
the United Kingdom-
In m3rry camtries ex:Lst or are set up, to monitor
the
legislaticn e.g. In that tar ceilings. are not - -
- such
organizations, although set up to police the
legislation, are freqjently
c=wulted, eq-mally wh- legislation is -xied, and
again omtwt with them
nay be beneticial.
Mus paper as=3es that in wny comtries, therefore,
there will be same
dialogue with Regulatory Authorities and that
there may be advantages in doing
so. In many cases -%xh rli-,---ions are mandatory.
However, geographical
variaticris in culture mist be identified and
taken into accatut. For exatTle
in the UK the Independent Scientific Ccmittee
prefer an ongoing discussion
with manufacb=ers prior to, during and subsequent
to, the evaluation of rxNei
processes. Failure to respond could lead to the
inpoisitian of an exc,-Mi~jgly
denanding test schedule. On the other hand there
is practically no dialogue
in the M. Ln
CD
7 he specific requirements of regulatory
authorities world wide are identified rl~
in Appendix 3, together with details (where known)
of advisory bodies, and ON
organizations delegated to police the
regulatict-r.. The more general NJ
irplications for product development are (Ii-l-A
next.
CD
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Few,latory Recpiirere&-% ard Product Truxvaticn
Straightforward regulatory matters such as a
requirement that the pack shows
deliveries of tar and nicatine arising e-ither
through legislation or by
voluntary a9.,-1 U.'st be o=plied with. These are
fully detailed in
Appendix 3 to this n0ts.
However, the greatest cpport:unities exist for
companies who anticipate future
regulatory requirements and who have produicts
ready to comply with any changes
which ray be reggired. In Some ca , crgaing dLalc~
with regulatory
authorities (as in the wo gives a clear indication
of possible faWm
requirements and may even lead to unsound
proposals being at-A&L-ed (again in
the UK, the in&stry views on the lack of relevance
of "shart to= N
biological tests such as the "Ames" test, proposed
for um in ranking products
on the UK market were accepted, at least in the
dxwt term).
The current scenario of Regulatory . on regional
basis is as
follows:
United Kirodam
Mw system here is unique. Me Independwt Scientific
Ccmittee (almost
excl~isively wmimlly qualified) bave in their
tenr. of reference a
r pirement to give advice to the Government and
DOustry. Me Government
then negotiate directly with rniustry arxi some of
the Ommittees'
---.ndations are accepted by both parties as the
basi ofabindirg
voluntary agreement- However, the irktastry (or
indivi&ml ccq-des) can
appr-ch the ccmittee directly on specific issues.
nia- fourth repar (L988) of the u ' ~ - lk=&
Scientific Committee made the
following L-.,-,Jati- which relate to future
product deve1cpnent:
[1,2 General policy]
Quote
3. The sales weighted average tar yield should not
be more than
]3 mg1cigarette by the end of 1988 and should
continue to decline
with a target of 12 mg1cigarette by the end of
1991. (para 12)
4. The tar yields of new bra nds should continue
to be subject to a
ceiling defined as the sales weighted average tar
yield of the
middle and low-to-middle tar brands during the
preceding
six-month survey period. (para 13)
5. As soon as possible there should be an upper
limit of 16 mg tar
per cigarette placed on existing brands on sale,
reducing to 15
mg after two years and becoming 14 mg for ALL
brands after four
years. (para 31)
6. While the overall aim should be towards
reductions in the tar;
nicotine ratio this should not be through the
enhancement nor
solely through the maintenance of present-day
middle range
nicotine levels (around 1.3 mg1cigarette). In
general the sales C:)
weighted average nicotine yields should fall, and
on the lines M-1
of the suggestion made in our Third Report (para
20) there 0\
should continue to be some brands available to the
public with
nicotine yields below I mg and with tar yields
reduced to a
proportionately greater extent (be7ow 8 mg). (para
34) CD
Uli
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7. Manufacturers should take steps to reduce
carbon monoxide yields
of all brands of cigarettes and the yields of new
brands should
be subject to a ceiling defined as the sales
weighted average
carbon monoxide yield of brands In the middle and
low-to-middle
tar bands during the preceding six-month survey
period. (para 20)
8. Government and the tobacco industry should
consider what further
action could be taken to persuade more smokers to
favour low tar
brands. (para 33)
And, on a longer term basis:-
There should be further investigation of the
possibility of
developing a range of short-ter2 tests to predict
the
carcinogenic activity of smoke from wdified
products. (para 40)
10. The Investigation of yields of other smoke
components as
identified in the Third Report (para 27) In
representative
cigarette types should continue. (para 43)
11. The Committee should continue to scrutinize
all new developments:
and In addition to the regular determinations of
tarICOInicotine
carried out by the Laboratory of the Government
Chemist, there
should be studies in newly emerging products of
the composition
of particulate and gaseous phases of the smoke and
of the effect
of different sooking patterns on yields and human
uptake. (para
44)
16. The tobacco industry should pursue research
into ways of reducing
the amount, irritancy and other deleterious
properties of
sidestream smoke fron all tobacco products. (para
73)
Unquote
While the future of tbese is uncertain (partly
because of the
unresolved future nature Of the if wW, betmm the
ISC and the
EB::), if adopted by the UK Gom they would set
very clea lines within
which future pr~ knovaticns wadd have to be
targeted and v"3ted- Flor
eoGanple ., - - 31 would require a - -Jderab3e
investment in Aerosol
Hyysics and Respiratciry ftysiology to caq-t-itly
eVl- the identified area.
C---UY speakirv the influence of the = is greatest
in countries of
the comm=-mlth.
in Germany scoe ten Government organizations are
respot ible for the
regulatory issuies that relate to the Ticbaoco
Industry. These are identified
in Appendix 4.
As an exnple of work that could impinge directly
an future produict
developtent the Federal Health Lwtitute
(F4V4--gC=-X2-1e1tSaMt) is
investigating specific substances ca7tained in
tzba= -ke (Nitrosmunes,
Benzpyrene and Fbrmaldehyde) and there,is a
proposal for a hybrid list of
smoked v.&%AA=itS (the so called 'M=-au" Index) to
be developed as well as
L_t:~ _. 11 lylations for lower tar to niattine
ratios. Them is also legislation
in respect of maximum residue levels for 11
pesticides, recamarded levels for
a further 71 pesticides, and a further limit for
ncn-registered pesticides.
Tn Geniany discussions with Faegulatory
Authorities are possible but are nearly
al,,mys carried cut on an informal basis by
sciext-ists who bridge the gap CD
bet.veen industry and "irdependent" regulatory
authorities. -4
X~'
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The mifluence of German regulations is greatest in
Europe. For exmple, the
Medical Board in Finland have given a favourable
response to the use of German
regulations for additives in Finland.
Other nlr-n --o-Hes
Ddsting F-platory t in other European countries
vary considerably
for exanple with regard to tar ceilimp and the use
of additives (in same
countries them are no regulaticns f= additives).
Germany, italy is
unique amcng B=pean ccuntries in havirxI a legal
requirement for wavimim
resubje levels for pesticides. However, the EEC
Draft directive on tar
ceil.ings is 1LImly to P4=&uAe local requiranents
in mo/199i. 7he Eec view
on tobacco additives is not yet known.
FM - -&,ies
Mile anti --king pressures are ext--ly high,
regulatory reggirments vary
considerably from Finland on the one band (Tar
ceilings simila to
proposed in the EEE to Austria on the od-Ar (Tar
aaUIM of 25 mg).
Mvere is a draft directive in the EEC for tar
ceilinc;s of 15 xg by the ed of
3.992 and 12 mg by the end of L"7, exemption beirV
for Greece. If this
passes U--xjh the Fs+~-nt stages of the EEr-
legislative procedures it win
have to be implemented by ESC countries in
1990/1991.
M'Pe EEC in the context of the Europe Against
cancer 1,_,,
(docunent. CC24 (86) 717 final) has al proposed
that there should be
reorientation of t prrA-lirn tzmerds "less tcodr-
varieties". The
Oamnission of the is also interested in Methods of
detecting tm (cellular
genet-ic material) damaging agents in I-- and have
issued the follading
statement through P. Bot=deau, Environment and
Ndn-nur-lear Energy Pasearch,
Directorate-Ger*xal for Science, Pasearch and
Development, of the
European Cct--iti-, Rn-sels, Belg-=:
"Ibe European Coczunities have iUp-t-'It
regulatory .-.*..-IbiIities for
environmental protect~ic~. Mx- incIude, the
protection, of wcdm=, of the
general pqnhttim and of the awircrnent f-rm rL--Jm
due to awiranwtal
chemicals - both Irxw' -4--1-19 and already presen
In the
envircrnent. The scientific basi for such
regulations is, to a significant
degree, provided by envi-A~A~l research at the
leve3. of the cm=nity."
This statanant is an lrrtzr-%-+i-n to "Methods for
detactim rn dmnagin;
agents in Himons". ILRC Scientific Publication No.
a9, Lyon 1988, a review of
a 1988 conference at which there were some 6a
papers, 5 of which investigate
smokirg as a source of environmental ctw-ir-Ala.
If sripcifie- smo)w rhpiml,,
were to be found to cause a significant increase
in rm adducts in _q=kers
then there would be enormous pressure to regulate
the delivery of Mr
.h
materials because, regardless of the scientific
arguments, this is a subject
of 17mTense concern to the general population akin
to nuclear energy. Mle need
for monitorirg these areas will be considered
later.
With the current exoepticn of additives,
activities in the E3DC may set the Ln
trend elsewbere and this could now include Eastern
bloc countries. C:)
r,_'
(71
PIJ
C:)
--4
Qn
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As yet tbexe has been no approach to the EEC to
ascertain their attitude-
towards =1ified products, an area in uhich the UK
TSC has given qualified
behin:1-the M4)port. it is that this area be
eVlored
with the EEC.
M&
There is a voluntary Z-jLu-wE-j& to show tar and
nicotine deliveries an
advertisements, measurement being by a method
agreed by the Pederal Trades
Ommissicn (FIq. In addition the Departn~ of Health
and Dmen
Pasources are currently examinirzi a , - or - q
its List of all additives used
by the US tobacco in1istry. As yet they have m3de
no cmvent or judigement,
an this list or on individual additives.
There is also a legal requirement for --i--
residue limits for 16
pesticides although there are no limits for other
pesticides approved for
use in USA.
Most recently a pxcposal for the regulation of the
Trbaoco, Irkbstry has
been put forard by Senator BNvxd Xemiedy, Which
MIght involve
mq*nditux-e of up to $200,000,000, and with a
broad remit for caltrol of
the industry on issLm such as the use of
additives.
Health arxi Welfare Cxv4a, a Gov-,-& , pjblish
listings of
clck" 3a+-e nicotine and carbon U-X=ide levels
quarterly bat them are no
upper ~~ts - M.-- - no other requirements.
Cmxlm-sate and nic&-ine levels are published by
the Td=co Institate of
Japan, an organization m K z :-*Ing both Gove~L,
-& and lrxtmtry but there
are is no regairement for No other requirements.
MAR Countri-
Again Uwe are aft=g Witi-smm'drv pressures led by
the Go~~ of
As,jait and SwAl Arabia &cUrq through aranizations
such as SAM (Saudi
Arabian UduJaLJ~. ) - Theset have led to the
arbitrary
introduLtim of delivery ce4lings, current maxim 12
zq tar, o.s ag
nicotine'. Mxse low figures may be re&xed even
Amthw in the near
fUbxre (tar to 8 z2f.)
Other Coun-i-
The position varies but tends to follow that in
developed c=rtries with
which there my be some affinity e-g. South and
latin America relate to
USA and Con=vealth countries relate to UK.
Ln
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--I
ON
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PIT and RecP11 atorv I
BAT objectives in relation to Regulatory Iss; can
be suz=arised as
follaws:
1. To ensure that regulatory canstraints uhich are
not
scien0fl-Ily justified are not, introduoe&
2. Th ensure that BAT prcducts (both new 1 .1 ..
quotions of
ccrwentional prah=ts and innoivative designs):
(a) c-ply with the r-pirments of raplatary
auftwities
(b) any additional C-Pany regAremm-Its, arising
ftm ST's
of the state of sciertific knowledge (duty of
care)
(c) meet any r--sary narketiM req'i I
(d) increase m&.et share.
3. To anticipate ftture, regAmments; of regulatary
authwities, and
to try to influence tbem.
4. To ensure that BAT prah=ts are disadvantaged as
little as
possible by the iq=itim of unscund testing
procedures or
through competitors activities.
To achieve these objectives the follading key
activities can be
identified:
1. To be aware of the current views of regulatory
audxz:ities.
2. 7b establish -q-W Tddelir-, particularly V-Rxe
Mere are no
regulatory requiremayl-, (either in partiailar
scientitic areas or
in particular countries), or for use in crt-WiM
disoussi= with
regulat-y authorities and to carry cut any
rmosessary zemacl to
clarify regulatory issues.
3. To critically review the scientific literature
relating to any
additive or pmoess, JALI J- for U- in a*xetes,
agairst
reTaLatiory require-ft and oampany (y,iAal irM. Th
adVift, With
external consultants if r-,y, an any ftwtber , Ir
necessary to coWlete an adequate exminatim of any
Proposed
additive or prooess. Th enSUre that such necessary
research is
completed to a-eptable scift*Atic standards and
the results
appraised.
4. To put in place and use the r----%,y ca*zr-ts
to adALw
effective mmication of the BAT position to key
people.
in practice it is -,,; convenient to ocnsider the
managemert of this
area with regard to the internal anift external
aCt3.VltleS Of the BAT CD
Group. cbjective 2 and key activities 1-3 are
internal activities of rI_I
lip BAT Group, the remairiler are external. CTI
r"';
CD
--4
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- 8 -
Tnt.rp.l Cbie&iv,-
Thp- BAT G=u; should be organized along the
following lines:
Iderytifica== of
Ddsting & =ici;xted
T= and -r
for Action
cmeirnation -_Imt
fall within G=.* St=tegyI - - - - - - - - - - - -
V Relevant - - - - - -
BAT Group External
Research Fhowledge
L- - - - - - - - - - - - - -
MT
knowledge - - - - - - - - -
Base and
Guidelines
I
CAC RED Dqnxtmerits
L t, "I C
Tcbacco Strategy
Rwiew Tom V
03 vered by Grcmp
cmq-A-, eg-cially
Agmed, at annual
neeting of Research
Policy Gr-V
Arises f= BAT
G=V Research
P-.+-
pagulat-Y
pb*d-ments cac O-Pud- Activities
(in apprcpri- Marketing DVUt ) in ralatim
country) ) to 4mcific,
) Existing Products ) Markets
1'ro=
.Ype Now Prodwts Modifications to
ard lalidation* d-Ves in F-julatory
R I I or in BAT
GrCUP Policy
7 his may be ra-c-aired at a later stage (e.g. on
specific products immediately
prior to laurch)-
C)
NJ
ON
C)
_--j
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- 9 - proposed
Action by
Ftecommendation-- for action --r-th i n RkT Grn -
0 rcli -1 i r=
("Ir 0on-Mes)
1. Exten-1 k-wledge (e.g. info=atim obtained at
BAT Q=p
oftenial conferences) is not always circulated
effectively by Group camanies to the centre. 7his
a=jld be irpxvved.
Die to other demands on the time of CL,.,k-,,.Le
R&D AIH/IMr
Depart-7t, Millbank the cngoing review of
scia*.Jfic
papers is becoming increasingly difficult to
mamtain.
2. Coordination, of the appraisal of additives
across the BAT Group
Group sIxmId be intrah-d (agreed in principle RM
1989,
riot yet implemented).
3. Intro~ion of syst- '-or ensuring guidelines are
met in AUVREr
operating companies.
4. More work should be car---ed out to
invest-Igate the AIK
pyrolysis products of additives/materials used in
cig--tt- (again, agreed in principle RPG 1989).
5. More attention. should be given to the probl-
likely to. BAT Q70W
be associated with valie-ting potentW new
6. In future Regulatory Iss; , including
comideration of AUVCAC
their Upat on am&ict Develcpnent, W3-U be given
higher
priority in the Group R&D Strategy meetings.
L .7
C,
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ExtexTr-1 01:r~--&ives
Essentially objectives all relate to getting the
BkT view an
regulatory issues accepted externa-UY as far as
possible. M-Lis is dwe by
lobbying by various to target graips as di--A
earlier.
However, thF-=--- are maw ons which do this and
these are now
1 i nted:
ortmnizaticr-s wi+-h PAT Tnvolvers-nt
1 Either d=ectly of indirectly the BAT Group is
involved with all of the
follading , vho wM lobby an tobacco-related
issues.
Manufac----ers' associations may of course take a
point of view different
frm that of BAT, notably on regulatory iSSLM With
direct ommacial,
inplicat:~- e.g. cigarette testing methods for
BAR=AY and currmytly
the minin= level of tar (1, 2 or 4 mg).
BAT indh=ries and its principal sul-idiarjes
BAT in&zscries Associates (e.g. IMAsa))
BATCo
BATCo -;-iAiavies
BATCo Associaties; (e.g. SkandinwrLsk)
aATM Ftiendly i- (e.g. Tiedemann's)
Manafact=n= Assocjzticns (e.g. Tkq
A--cci-ti=s of Manufacturers Associations (e.g.
CECCM)
INFUTAB Doin role infonostion M-m-mination)
CCRMM~
2. 0rqaniz&"-cn:s without PAT Tnvolv-T-,nt
The follawing organmtions with uhm BAT is not
directly involved WIth
will also lobby on issues.
Fbr the Arm i rist the Trvi"-! , V
T.I. aM4 and any other Map,f-h--ers A.S.H. and
simila organizations
A-.oc i ---4 en B&T is not involved in.
world-wide.
F.O.R.E.S.T. & slynila org. world-wide. Ywt
-iiel/scientific Auth.
Occasional Medical/Scie7tific Auth. Doctors etc.
Politicians Politicians
Standards arganizations
politicians
Discussion
Given the lary-- MMber of organizations who may
express views an regulatory
issues, scue c=Iination is clearly rm-c---Ary
within the BAT group to ensure
that a ocz..cx view is put over unless th~e are
special reasons for 10=1
variations. rcLthin the various med)ers of the
indistry, coordination of
industry-related activities is also desirable: if
this is not possible then Qr
knowledge of =cpetito- positions, where different
from that of the BAT Group, C:)
is required. saever, further difficulties arise
from the rationalization of 0,
different interests within specific BAT coapanies
i.e. tar minima, attitudes
towards testim of Roll-Your-Own tobacco, use of
particular additives, etc. and
these omplic-acions furt - strengthen the case for
central coordination. C)
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BATCo document for Province of British Columbia 25
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ReconTer-dations; for Coorrii-tion of Policv
(rxternRl)
1. It is assumed that the broad principles of
Policy will be set by the
Tobacco Strategy Review Team.
2. in ccamm with sn*Jxq and health issues the
regulatory issues di-,---A
here have a sciertific:/medical basis of
increasirq ccuplexity. Hance
the focus for the BAT response should be Corporate
R&D Department,
working within the remit of the Tobacco Strategy
Review M&m.
3. Detailed Policy on Regulatory Issues for all
BAT Group Coqpanies should
be set by 0orporate R&D Dq=tment after
consultaticn with the
following, as necessary:
(a) 0-airman of BATCO (Director responsible for
R&D Department).
(b) Other CAC Ttbaoco Ompanies and if appropriate
BkTCo subsidiaries.
(c) Legal Department BA=-
(d) Public Affairs Departnert BA=.
(e) M-keting Depart-it BA=-
(f) Leaf Department BkMo.
All those ..,ActaL~xad With the implementation of
the policy in individual
conpanies should be advised through No. 1s that
activities mist
relate to the policy set out by Corporate R&D
Departwnt, who will have
responsibility for coordinatug the Group's
external activities in the
areas defined in this note. Position papers on
Regulatory Ism win
be comurdcated to No. Is by Corporate REM
Department. (Mis follows
BkTco policy on hand].ing Smo1ang and Health Ism
and is carzistent
with the fact that marry Pagulatory Authorities
deal both with Smdoxg
and Health Lssues and the Regulatory matters
defined in this
5. Implementation of Policy will largely be
carried out within individual
BAT Intastries or BUM subsidiaries, and by a
variety of ir%Uviduals,
who may or may riot have scientific training. The
cmLs =.wt be on these
irzilviduals to CMISUlt With "I-Le R&D Depart:ment
if they feel unable
to cope with the scientific o=plexity of any of
the J so , and when
special J st assistance (Dr Thornton, Dr Boyse, Mr
Mitchel.1 or Mr Dymcrxi)
may be required. This applies most obviously to
rli--icns with
kncwledgeable eAen-al authorities wk-D may be
hos-tile to the industry.
it is difficult to be speci ic in this area but
the CAc countries are
m- - likely to have their own R&D staff able to
assist.
6. With regard to specific orWizaticns the foumLng
are
made:
(a) Natioml Marxifactll-rs Associations (NMA's)
In countries where BAT sells cigarettes BAT should
be represented on
these associations with the objective of getting
BAT views accepted.
There is one anarralcus organizaticn, TAC (Uhl,
where BAZ does not sell (-n
cigare-t-tes. Ho;,7ever, the in~t u-Lfluence of
the UK, particularly in
Coamrwealth countries, justifies continued
mmnbership. M-ds should be
~Lwiewed circa 1992 with the advent of the
harmonized common market and
in relation to CECCM. N:
CD
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BATCo document for Province of British Columbia 25
October 1999


- 12
(b)
The role of NMA's MY charge in relation to
regiaully hased
organizaticns such as CEOCH. Circa 1992 there my
be a ca for
oansiA-ring whether it is r---y to belcrzj both to
CM34 arxi to
NMhls, altb-gh in principle actim at EEC level
re*drw
. At present, with fcr caMle no sign of
ban=ivation cn additives in the ESC, it would
rxxessary to
balwig both to CDOCK and to individual NM;Lls.
(c) lff=
On Regulatory Issues there Would appear to be a
strifatly I imi ted role
far MOXYMB as an informatim semimfing
orgazii-tion.
(d)
BAT Group membership Is rxw strcng and with a wide
g&-grarhical spread
the cml---- In recent yeaxs this m9mimtim has
beccime
Mw=m iqxwtant, partly V-x-- of its delegated role
in cigarette
delivery measurement. We shculd continue to sWort
tiLts crganimt
,icn
but the activities of delegates, at all levels,
should be led
and coardinated. by G-k-Late R&D in Millbank
(AuVRET).
(e) or-nizatior- without PAT Trwolvement
(i) Naticral Manufact=ers A-x0aticris
Obviously if we are not members there are no
d1reCt CppCMtUn1t.Jes
for influence and in the ca of the T.I. in the M,
%hich we
C='M rejoin, this is a risk to be x-midered.
(ii) MqdicaVScientific Authorities
Giving encou-j--A- to reputable irLk1,er4.jL
scientists to Ictby
regulators is a legitimate activity and is carried
cut in the
Group-
7. VIT Omwit--t
If the BAT Grcup is to be an effective of the
orgwdzatia-z
listed above, tcp m-agement --t reco7LLze this ard
allow fcr the costs
in time of senior staff and mmW involved.
REr/IEW/SC
30 th January 1990
Ln
CD
r1 J
cr"
C-D
BATCo document for Province of British Columbia 25
October 1999