Reaulatory Igo= and the Grow's Tdpacw Business
CONTENTS
Introduction page 1
Direct Regulatory Issues page 1
Regulatory Authorities Page 2
RSgUlatCrY Rsquirelum7ts and Product innovation pa" 3
BAT and Regulatory issues Page 7
PaccurAndatiom for action within BAT Grow page 9
for coordiration of Policy (External) ... Page 11
Appendix 1 Indirect Ehvircnmental issues
Appendix 2 Possible Scientific Mvelcpm*s
AppertUx 3 pe@@ of Regulatmy Authorities
Appendix 4 Existing Ret
.julatory Procedures in Ge=wW
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EXULATML-ISSM AND 7ME M:KXW'S -MBACM BMD4ESS
Introducticr
In the 199o,s a probable scenario is that the trend of the 19801s, tending to
favour the --r--Larex at the expense of the producer, will continue and way well
accelerate as cther preoccupations such as East/West tensions diminish. This
will lead to ix @-ingly stringent regulations controlling consumer- products,
partly as a result of the activities of "green" and health-conscious pressure
qroLzps, altr=xt Governments are generally reluctant to legislate for the
extreme vivs of such groups, even for tobacco. However, it seas likely that
the tobacco irdustry will continue to be at the forefront of such regulatory
activity as is enacted and even in the absence of specific legislation
consLmrs -.-411 require products that are sea to rake some concessions to
these issues. E*tmples include lead free patrol, Aecaffeinated coffee, and
from the tcbacco industry ultra-low tar cigarettes, and pesticide-free tobacco
etc. ) .
in terms off the cigarette market response to these issues will be of crucial
urpor-@anca. Great cpporbauties will arise for the manufacturers who best
anticipate are respond to the constraints imposed in the rarket place,
althcugh in addi,:don to product innovation support may be necessary for N-
existirg brands.
The contrave--sy C74er BARCLAY arose principally from a Rdlip Morris view that
it was an -ri-c-ative and successful contenider in the ultra low tar segment,
which would be----we increasirgly important as regulatory pressure forced tar
ceilings do.T.-weards.
7his paper seeiks to identify the regulatory issues which will directly impact
on the Group's tobacco business in the next ten years, and concludes with
proposals fcr their management.
In addition tharre are other aspects of Regulatory Issues to be considered.
ibe rcre gener-al aspects of an envixonmentally-conscicus world will have
important implications in the 1990s for all industries. For example, the
agreement to reduce emissions of fluorocarbons (CFIC's) has already had direct
effects within the BAT Grap i.e. the decision to discontinue the G-13
expansion p---xx?ss. 7his area will be considered in Appendix 1.
Finally, there --ay be other events or scientific deveJLcp=uTts which ray or
may not be taken up by regulators, and which nay riot be directly related to
the Lrdustry, 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 AIDS or a major scientific breakthrough undermining current
attitudes to the cause of disease) are both difficult to forecast and almost
impossible to controls As it is debatable whether they strictly fall within
the scope of regulatory issues they are briefly considered in Appendix 2.
oirect Reaulatcry Issues Mxistira and Anticipatedi
the followirc t--Vics are considered to fall within this area, all of which
relate to prrdLct development.
1. (a) Ce-;, inas for deliveries of individual smoke components in mainstream
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w.-cke ind associated methods for measuring delivery (Tar, nicotine,
cartcn ronmcide and such other smoke components wiuch ray be
ident-fied by regulatory authorities).
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(b) Ceilings for deliveries of individual smalm components in
sidestream smoke (again tar, nicotine etc'
2. Evaluation of novel processes; wtiich may be used in future
cigarettes against ri and considerations of
reasonable safety.
3. Further evaluation of additives, agrochemicals, or any other chemical
added to tobacco at any stage prior to sale.
4. Cigarettes with low burn propensity.
5. Biological tests for measuring "tar," quality.
6. Biochemical tests for meas=ing interactions With the
eriviroment (e.g. measurement of EM adducts).
Underlying these specific regulatory matters are the more general smoking and
health issues of which the following am those frequently raised by
regulators:
(a) Associations be sroking or environmental tobacco smoke and
disease.
(b) ctupensation.
(c) Addiction.
Recrulatory Authorities
In most cases the ultimate regulatory authority is the Government of the
country enacting legislation which regulates the industry. However, them are
frequently advisory bodies who initiate proposed legislation and who may be
prepared to consider the views of the tobacco industry at various stages
before the legislation is finalized. Direct contact with politicians is also
possible. In some cases the industry is regulated on a voluntary basis with
sme opportunity for modifying the p-p- I basis of the agreement, notably in
the United Kingdom.
in many countries organizations exist or are set up, to monitor the
legislation e.g. in determining that tar omilings are not exceeded. Such
organizations, although set up to police the legislation, are frequently
consulted, especially when legislation is amnded, and again contact with them
rmy be beneficial.
1his paper assumes that in many countries, therefore, there will be some
dialogue with Regulatory Authorities and that them may be advantages in doing
so. in many cases such discussions are mandatory. However, geographical
variations in culture =ist be identified and taken into account. Pbr exarrple
in the uK the irdeperdwt scientific Oommittee prefer an ongoing discussion
with mvvf acturem prior to, during and mAx;equent to, the evaluation of novel
processes. Failure to respond could lead to the inpositim of an exceedingly
darm-ding test schedule. on the other hand there is practically no dialogue
in the LISA.
The specific requirements of regulatory authorities world wide are identified
in Appendix 3, together with details (utiere known) of advisory bodies, and
organizations delegated to police the regulations. The more general
inplicatiom for prah& develcpmt are disass@ next.
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Regulatory Pz-auirements and Product Lnnovation
Straightforward regulatory matters such as a requirement that the pack skx7ws
deliveries of tar and nicotine arising either through legislation or by
voluntary agreement must be ccmplied with. 7hese are fully detailed in
Appendix 3 to this note-
However, the greatest opport=Uties exist for companies who anticipate future
regulatory requirements and who have products ready to caqply with any changes
which may be required. In saw cases, ongoing dialogue with regulatory
authorities (as in the UK) gives a clear indication of possible future
requirements and may even lead to unsound proposals being abandoned (again in
the UK, the bxbistry- views on the lack of relevance of "short tam 11
biological tests such as the "Ames" test, proposed for use in rw@@ products
on the UK market %.vxe accepted, at least in the short term).
7he current scenario of Pagulatory Ptequirerents on regional basis is as
follows:
United. Kirxzdam-
The system here is unique. The Independent Scientific cormittee (almost
exclusively medically qualified) have in their terms of reference a
requirement to give advice to the Gover.-mient and Industry. 7he Goverment
then negotiate directly with irtImtry aid scme of the O=vaitteesl
reconverdations are accepted by both parties as the basis of a binding
voluntary agreement. However, the irdustry (or individual caqmnies) can
approach the Carmittee directly an specific issues.
7he fourLh report (1988) of the Independent Scientific Comittee made the
following recommendations 6ftich relate to future product development:
(1,2 General policy]
Quote
3. The sales weighted average tar yield should not be more than
13mglcigarette 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 brands 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) .
S. 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 mglcig,rette). In general the sales
weighted average nicotine yields should fall, and on the lines
of the suggestion made in our Third Report (para 20) there
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 e.itent (below 8 mg). (p a ra 34)
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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. (pars 20)
8. Government and the tobacco industry should consider what further
action could be taken to persuade more smokers to favour low tar
brands. (pars 33)
And, on a longer term basis:-
9. There should be further investigation of the possibility of
developing a range of short-term tests to predict the
carcinogenic activity of smoke from modified products. (pars 40)
10. The investigation of yields of other smoke components as
identified in the Third Report (pars 27) in representative
cigarette types should continue. (pars 43)
II. 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 smoking patterns on yields and human uptake. (pars
44)
16. The tobacco industry should pursue research into ways of reducing
the amount, irritancy and other deleterious properties of
sidestream smoke from all tobacco products. (pars 73)
Unquote
while the future of these ".. andatims is uncertain (partly bemuse of the
unresolved future nature of the relaticrshdp, if any, between the = and the
EEC), if adopted by the UK Government they would set very clear lines within
which future product innovatiom would have to be targeted and validated. For
exavple recommendation 11 would require a considerable investment in Aerosol
Physics and Respiratory Rrysiology to caqxtently explore the identified area.
Generally speaking the influence of the ISC is greatest in member countries of
the Commonwealth -
Germany
In Germwiy some ton Government organizations are responsible for the
regulatory issues that relate to the Ttbacco Industry. These are identified
in Appendix 4.
As an example of work that could impinge directly on future product
development the Federal Health Institute itsamt) is
investigating specific substances contained in tobacco smoke (Nitrosmines,
BenFpyrw* and Formaldehyde) and there is a proposal for a hybrid list of
sTTiok( (the so called "Thuraux Index) to be developed as well as Y
tiom for lower tar to nicatum ratios. There is also legislation
in respect of maximum residue levels for 11 pesticides, recommended levels for
a further 71 pesticides, and a further limit for non-registered pesticides. 0
in Gerrany discussions with Regulatory Authorities are possible but are nearly (__4
always carried out on an informal basis by scientists who bridge the gap C7%
between Lndustry and Ifirdeperx*.nt" regulatory authorities. 00
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The influence of German regulations is greatest in Europe. For example, the
Medical Board in Finland have given a favourable response to the use of German
regulations for additives in Finland.
Other aMMM Countries
Existing Regulatory requirements in other European countries vary considerably
for example With regard to tar ceilings and the use of additives (in some
countries there are no regulations for additives). Besides Germany, Italy i,,-
unique arong European countries in having a legal reqUrement for mximL=
residue levels for pesticides. However, the EEC Draft directive on tar
ceilings is likely to wAmrcede local requirements in 1990/1991. The EEC view
on tobacco additives is not yet known.
EFrA Countries
While anti ==kLng pressures am extremely high, regulatory requirements vary
considerably from Finland on the am hand (Tar ceilings similar to those
proposed in the Emc to Austria on the other (Tar ceiling of 25 mg)
EMC
llhere is a draft directive in the EEC for tar ceilings of 3.5 ng by the end of
1992 and 12 nq by the end of 1997, exefft*-ion being made for Greece. If this
passes through the subsequent stages of the EDC legislative procedures it Will
have to be implemented by EBC countries in 1990/1991.
The EEC Ccmission, in the context of the Europe Against Cancer programs
(domment CCM (86) 717 final) has also proposed that them should be
reorientation of tobacco pro@icn tawards 'less toxic varieties". The
carrussicn of the EEC is also interested in Methods of detecting EM (cellular
genetic material) damaging agents in humans and have issued the following
statement U=Ough P. Sourdeau, Erivircnment and Ncn-rR=lear Energy Research,
Directorate-General for Science, Research and Development, C=udwian of the
European cbmunities, Brussels, Belgium:
,m-,e European cznmwdties have iq=tant regulatory responsibilities for
environmental protection. 7hem include the protection of workers, of the
general population and of the environment from risks due to erwircnmental
chemicals - both 'new' chemicals and those already present in the
environment. The scientific basis for such regulations is, to a significant
degree, provided by environmental research at the level of the it
,This statement is an introduction to 17*thods for detecting CNA damaging
agents in amgmll, IARC Scientific Publication No. 89, Lyon 1988, a review of
a 1988 conference at which there were some 68 papers, 5 of which investigate
smoking as a source of environmental chemicals. If specific smoke chemicals
were to be found to cause a significant increase in Cm adducts in smokers
then there would be enormous pressure to regulate the delivery of such
materials because, regardless of the scientific arguments, this is a subject
of immense concern to the general population akin to nuclear energy. M-ie reed
for monitoring these areas will be considered later.
with the current exception of additives, activities in the EEC may set the
trend elsewtmm and this could now include Eastern bloc countries.
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As yet there has been no approach to the EBC to ascertain their attitude
taw-a rds modif led products, an area in Which the UK ISC has given qualified
behind-the scenes support. It is recommended that this area be explored
with the EEC.
LISA
Therib is a voluntary agreement to show tar and nicotine deliver-as on
advertisements, measurmnent being by a method agreed by the Federal Trades
ccr-.dssion (FTC). In addition the Department of Health and Human
Resources are currently examining a composite list of all additives used
by t!-e ILTS tobacco industry. As yet they have made no comment or Judgement
r-i tntis list or on individual additives.
7@iere is also a legal requirement for maximum residue limits for 16
pesticides although there are no limits for other pesticides approved for
use in USA.
Most recently a proposal for the regulation of the Tbbacoo Industry has
been put forward by Senator Bdward mmedy, Which might irwelve
ex@-wrditure of up to $200,000,000, and with a broad remit for cottral of
tlie industry an issues such as the use of additives.
= 7e. @'
Health and Welfare Canada, a Government organization, publish listings of
ccnderisata nicotine and carbon monoxide levels quarterly b.M there are no
u-poex liruts. There are currently no other requiremwits.
Ccmdensata, and nicotine levels are published by the TdAcco Inwtibrte of
Japan, an organization repxvsenting both Goverment and Inlustry but there
ars- is no requirement for upper limits. No other requirements.
ARAB Countries
I there are strong anti-smoking pressures led by the GoverrrwTts of
it and Saudi Arabia acting through cranizations such as SAW (Saudi
A= ian Standards organization). These have led to the arbitrary
introduction of delivery ceilings, current makim 12 mg tar, 0.8 mg
nicotine. These low figures way be reduced even further in the near
fut-am (tar to a mg?).
Other Countries
The position varies but terids to follow that in developed countries with
utich them may be scum affinity e.g. South and Latin America relate to
USA and Commonwealth countries relate to UK.
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BkT and Reaulatort Issues
BAT objectives in relation to Regulatory Issues can be sixuarised as
follows:
1. 7b ensure that regulatory constraints which are nat
scientifically justified are not introduced.
2. 7b ensure that BAT products (both raw intratxtions of
conventional products and innovative designs):
(a) comply with the requirements of regulatory authorities
(b) any additional ccupany requirements arising from BAT's
assessment of the state of scientific knowledge (duty of
care)
(c) meet any necessary Marketing requiretwits
(d) increase market sham.
3. 'Ib anticipate future requirements of regulatory authorities, and
to try to influence them.
4. -Ib ensure that BAT products are disadvwitaged as little as
possible by the inpositicn of unsound testing ptnoodurer. or
through c=petitors activities.
To achieve these objectives the following key activities can be
identified:
1. To be aware of the current views of regulatory authorities.
2. To establish ccaparry guidelines, particularly where there are no
regulatory requirements (either in particular scientific areas or
in particular countries), or for use in at-goincl discussions with
regulatory authorities and to carry out any necessary research to
clarify regulatory issues.
3. To critically review the scientific literature relating to any
additive or process, proposed for use in cigarettes, against
regulatory requirements and company guidelines. Th advise, with
exterml consultants if necessaxy, on any further research
necessary to complete an adequate eomiinitian of arry proposed
additive or process. To ensure that such necessary research is
completed to acceptable scientific standards and the results
appraised.
4. To put in place and use the necessary contacts to achieve
effective ccmunication of the BAT position to key people.
In practice it is ncmt convenient to consider the management of this
area with regard to the internal and external activities of the BAT
Group. objective 2 and key activities 1-3 are internal activities of
the BkT Group, the rwainder are external.
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internal objectives
The BAT Group should be organized along the following lines:
I
identlficaticn of CAC R&D Departments
Existing & Anticipated - - - - - - - - - - - -
Issues and Proposals
for Action
I
Confirmation that these - - - - - - - - - - - - Tcbm= Strategy
fall within Group strategy Review Tom
Relevant - - - - - - Ctrve@ by G=V
BAT Group EKternal C=panies, especia.11y
Researrh MWwledge Scientific Research
Group-
L- - - - - - - - - - - - - -
Agreed at annual
MOetirKj of Pasearch
Policy Grow
BkT Arises from BAT
knowledge -- - - - - - - - - Group ReseArch
Base arxi PrograWle.
Guidelines
Regulatory
Reqairaments CAC Cmq@es Activities
(in appropriate in relation
country) to Specific
markets
Prmducts
Prototype Now Products Modifications to meet
and Validation* changes in Plegulatory
PAquiremwft or in BAT
Grow Policy
This ray be required at a later stage (e.g. on specific products i=ediately
prior to launch).
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Action by
Ftg@=igm for action Within BU GMm fiWaMUM
CRC Cmyaniesl
1. External knowledge (e. g. informatien obtained at BNr accup
external conferermms) is riot always circulated
effectively by Group companies to the centre. This
skx@d be ivproved-
Due to other demarzLs on the time of Corporate R&D AtH/F=
DepartmeM, Millbank the arqoirq review of scientific
papers is becoming increasingly difficult to maintain.
2. Coorainaticn of the appraisal of additives across the BAT Group
Group &xxdd be intro*x:ed (agreed in principle M 1989,
not yet iMlawnted).
3- InUoduction of system for ensuring guidelines are rat in AUVF=
operating ompanies.
4. More work shculd be carried out to investigate the ALH
pyrolysis prcducts of additives/rateriabs wed in
cigarettes (again, agreed in principle M l9sq).
5 . More attention should be given to the problems likely to BAT Grvup
be associated with validating potential now
products.
6- in future Pagulatory Issues, including consideration of AUVChC
their mV.&- on Product Dwaacpnent, will be given hiow es
priority in the Gwoup P.&D Strategy rAetinge.
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External =ectives
Essentially these objectives all relate to getting the BkT view on
regulatory issues accepted externally as far as possible. ads is done by
lobbying by various organizations to target grays as discussed earlier.
However, Ule-re axe many organizations which do this and them are rai
listed:
Organizations with BAT Involverent,
1. Either dixectly of indUrectly the BAT Gra* is involved with all OC the
following organizations, who will lobby on tmba=o-rejated ,
Ysanufactxa-ers' associations my of course WM a point of view diiierent,
from that of BAT, notably on regulatory issues with direct cwne=ial
implications e-g- cigarette tAsting methods for BmKMM and C=rently
the minimum level of tar detarminations (1, 2 or 4 mg).
BhT Industries ard its principal subsidiaries
BAT Inilustries Associates (e.g. DCOM)
BATM
BATCO II:zubsidiaries
BATCO Associaties (e.g. Skandinavisk)
BkTCO Friendly CmPanies (e.g. Tiedemann's)
Manufacturers Associations (e.g. MC)
Associations of Manufacbirws Associations (e.g. accm)
n*'OTAB (main role information Aissenination)
cord=
2. Organizations without- BAT involvement
The following organizations with wham Bn is not directly involved with
will also lobby on tobacco issues.
For the Industr-i Against the InMg=
T.I. (USA) and any other Manufacturers A.S.H. and similar orgwdzations
Association BhT is not involved in. world-oide.
F.O.R.E.S.T. & similar org. world-wide. Most medical/scientific AL*h.
occasional Medical/Scientific Auth. Doctors etc.
Politicians Politicians
Neutral ?
Standards Organizations
Politicians
Discussion
Given the large Mxber of orgartizAtions who way express views on regulatory
issues, some coordination is clearly necessary within the BAT q to
roup, ensure
that a ca-a-z-an view is put over unless there am special reasons for local
variations. Within the various wsedbers of the industry, coord:imticn Of
irdustry-related activities is also desirable: if tl'ds is not possible than
knowledge of ccaq)etitors positions, %ftwe different fr= that of the BAT Group,
is required. However, further difficulties arise from the rationalization of
different interests within specific BAT ampnies Le. tar miniza, attitxks
towards testing of Roll-Your-Own tobaoco, use of parUcular additives, QW. and
these amplications An-ther strengthen the case for central coordination.
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BeggmwoAtions for Coord"'tion of Policy (Extoxnall)
1. It is assumed that the broad principles of Folicl will be set by the
Tlobacoo Strategy Review Ttam.
2. In cammm with MM" and health issues the regulatory issues discussed
here have a sc basis of increasing complexity. Hence
the focus for the BAT response should be Corporate R&D Department,
working within the remit of the Tobacco Strategy Review Team.
3. Detailed Policy on Regulatory Issues for all PAT Group C=,pwiies should
be set by Corporate R&D Depart:rent after camitatim with the
following, as necessary:
(a) chairman of BkTCO (Director responsible for R&D Departmmt) -
(b) Other CAC Tcba= Companies and if appropriate BA= subsidiaries.
(c) Legal Department BkTCO.
(d) Public Affairs Department BAMO.
(e) Marketing Department BATCo.
(f) Leaf DepartmM. &XTCo.
All those concerned with the implementation of the policy in individual
companies should be advised through No. Is that these activities must
relate to the policy set cut by Corporate R&D Department, who will have
responsibility for coordinating the Group's external activities in the
areas defined in this note. Position papers on Regulatory Issues will
be cawunicated to No. ls by Corporate R&D Departrient. (M%is follows.
Marx policy on handling Smoking and Health issues and is consistent
with the fact that many Regulatory Authorities deal both with Smoking
and Health Issues and the Regulatory matters defined in this paper.)
S. IMlementation of Policy will largely be carried out within individual
BAT industries or BATCo subsidiaries, and by a variety of individuals,
who may or may not haw scientific training. me anus =ist be en these
individuals to consult with Corporate R&D Department if they feel unable
to cope with the scientific cccplexity of aTry of the issues, and when
specialist assistance (Dr Thornton, Dr Bayse, Mr Mitchell or Mr Dymond)
may be required. This applies - - - obviously to discussions with
knowledgeable external authorities who maybe hostile to the industry.
It is difficult to be specific in this area but the CAC countries are
most likely to have their own RrxD staff able to assist.
6. With regard to specific organizations the following recommendations are
made:
(a) National Manufacturers Associations (NMA I s)
In countries vitw-re BAT sells cigarettes BAT should be represented on
these associations with the objective of getting BAT views accepted.
Ihexe is one wumalous organization, TAC (UK), where MT Aces not sell
cigaxettes. However, the indirect influence of the UK, particularly in
Commonwealth countries, justifies continued mater-ship, This should be
reviewed circa 1992 with the advent of the harmonized o=ron market and
in relation to CECCM.
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(b) CECCK
Tt,* role of NMA's rAay change in relation to regimally based
organizations such as CEOCM. C=--a 1992 them may be a case for
considering %twther it is rxxmssar@/ to belong both to CZaX and to
a=9ean Nmhls, although in principle action at EE)c level requires
C=3+-type organizations. At present, with for exmple no sign of
harmmization on additives in the ESC, it would appear necessary to
belong both to CBCr-M and to imL-vidual rMls.
(c) 2MMD
On Regulatory Issues there would appear to be a strictly limbed role
for INFOM as an information disseminating orgazli=tion.
(d) QORE@M
BAT G=xzp mombexship is now st--a-q and with a wide geographical spread
mcngst the ompanies. In recent years Uiis organization has booms
more irportant, partly because of its delegated role in cigarette
delivery measurenent. We should continue to support this organization
strongly but the activities of delegates, at all levels, should be led
and coordinated by ODrPOr&te R&D in Millbank (AUVREr).
(e) CraanizatigW without MT Tnvalvg--@.
(i) Natiaktl Manufacturers Associations
Obviously if we are not rapers tbere are no direct cpportunities
for influence and in the case Of the T.I. in the M, %rich we
could rejoin, this is a risk to be comidered.
(ii) Medical/Scientific Autborities,
Giving go - ot Iragevent to reputable indepwdent scientists to lobby
regulators is a legitimte activity and is carried out in the
Group.
7. BAT CogymitNent
If the BAT Group is to be an effective meater of the organizations
listed above, top managermt mist recognize this and allow for the costs
in tive of senior staff and money involved.
REWUN/Sc
30th January 1990
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