AUGUST 20, 1985
PROJECT EMN
P H A S E I
A. CONCEPT - NOT MARKETING ORIENTED
- NO FINANCIAL RESTRICTIONS
B. THEIR DEFINITION OF THE PROBLEMS
SURGEON GENERAL
ROYAL COLLEGE OF PHYSICIANS
C. DEFINITION TO INCLUDE RELATIVE VALUES OF
SPECIFIC
TOXIC COMPONENTS IN DIFFERENT SOURCES
I.E. SOIL, AIR, WATER AND FOOD
P.J. DUNN
L.P4
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D. TOXIC AGENTS - GAS PHASE AND P.ARTICULATE
MATTER
IDENTIFICATION BY CATEGORY
AND
IDENTIFICATION OF SOURiE
S.R. HASSEY
E. EVOLUTION OF THE SMOKING AND HEALTH ISSUE
MECHANISM OF MEDICAL METHODOLOGY
MECHANISM OF THE AMES TEST
BENCH MARKS OF EVOLUTION
M. BILIMORIA
F. EVOLUTION OF THE PRODUCT
GROSS REDUCTION
SELECTIVE REDUCTION OF SPECIFIC
SMOKE COMPONENTS
G. WHAT WOULD BE ACCEPTABLE AS A SAFER CIGARETTE
LITERATURE REVIEW
C. WARREN
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R E V I E W
1 9 6 2
REPRESENTATION OF
AMERICAN CANCER SOCIETY
AMERICAN COLLEGE OF CHEST PHYSICIANS
AMERICAN HEART ASSOCIATION
AMERICAN 14EDICAL ASSOCIATION
TOBACCO INSTITUTE INC.
FOOD AND DRUG ADMINISTRATION
NATIONAL TUBERCULOSIS ASSOCIATION
FEDERAL TRADE COMMISSION
PRESIDENTS OFFICE OF SCIENCE & TECHNOLOGY
MET WITH THE SURGEON GENERAL TO ESTA.BLISH THE
WORK OF AN
EXPERT COMMITTEE AND TO AGR.EE ON A LIST OF SOME
150 SCIENTISTS
AND PHYSICIANS QUALIFIED TO EVALUATE DATA ON THE
RELATIONSHIP
BETWEEN TOBACCO USE AND HEALTH.
THE SURGEON GENERAL SELECTED 10 FROM THE LIST AND,
THUS, THE SURGEON GENERAL'S ADVISORY COMMITTEE ON
S140KING
AND HEALTH WAS LAUNCHED AT ITS FIRST MEETING OF
NOVEMBER 9, 1962.
THE JUDGMENTS OF THE ADVISORY COMMITTEE LED TO A
SERIES
OF CONCLUSIONS RELEASED IN 1964 IN THE 'REPORT OF
THE ADVISORY
COMMITTEE TO THE SURGEON GENERAL OF THE PUBLIC
HEALTH SERVICE
ON SMOKING AND HEALTH.'
THE COMMITTEE CONCLUDED:
.CIGARETTE SMOKING IS A HEALTH HAZARD
OF SUFFICIENT IMPORTANCE IN THE UNITED
STATES TO WARRANT APPROPRIATE REMEDIAL
ACTION.'
-,j
4 h.
U-4
--j
110
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1 9 7 9
F I FTEE-N YEARS AFTER THE INITIAL 'SURGEON
GENERAL'S
EPORT' THE U.S. DEPARTMENT OF HEALTH, EDUCATION
AND WELFARE
:
UBLISHED
. SMOKING AND HEALTH A REPORT OF 'THE'
SURGEON GENERAL'
THIS REPORT IS A COMPENDIUM OF NEW DATA FROM MANY
SOURCES INCLUDING THE OFFICE ON SMOKING Z HEALTH
AND THEIR
REPORT ON THE EXPERT PANEL CLASSIFICATION OF
COMPOUNDS
IN CIGARETTE SMOKE.
Toxic and Carcinogenic Agents
Compounds in cigarette smoke have been classified
by an expert panel
into:
1. Those judged most likely to contribute to the
health hazards of
smoking.
(a) Carbon monoxide (gas phase).
(b) Nicotine and "tar" (particulate phase).
Z Those judged as probable contributors to the
health hazards of
smoking.
(a) Gas phase: acrolein, hydrocyanic acid, nitric
oxide and nitrogen
dioxide.
(b) Particulate phase: cresols and phenol.
3. Those judged W suspected contributors to the
health hazards of
smoking.
(a) Gas phase: acetaldehyde, acetone,
acetonitrile, acrylonitrile,
ammonia, benzene, 2-3 butadione. carbon dioxide,
crotononitrile,
ethylamine, formaldehyde, hydrogen sulfide,
methacrulein, meth-
yl alcohol, and methylamine.
(b) Particulate phase: butylamine, dimethylamine,
DDT, endrin,
furfural. hydroquinone, nickel compounds,
pyridine.
These compounds have been so designated not only
because of their
harmful actions but also because of their
concentrations in tob
smoke- Although other constituents are considered
toxic, they are not
present in concentrations deemed a health hazard
A number of tumr initiators, cD-c=inogen3, and
organ-specific
carcinogens have been isolated and identified. The
majority of co-
carcinogens remain to be identified. The increased
risk cigarette
smokers have for cancer of the esophagus, kidney,
and urinary bladder
suggests the possibility that cigarette smoke
contains unidentified
organ-specific carcinogens besides the known trace
amunt3 of
carcinogenic aromatic and N-nitrosamines.
SMOKING & HEALTH A REPORT OF THE SURGEON GENERAL
INTRODUCTION & SUMMARY
OFFICE ON SMOKING I HEALTH 1-30
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IN THE PREFACE TO THE 1979 'SURGEON GENERAL'S'
REPORT,
THE SURGEON GENERAL REFERS TO A 1966 PUBLIC HEALTH
SERVICE
REPORT THAT STATED:
THE PREPONDERANCE OF SCIENTIFIC EVIDENCE
STRONGLY SUGGESTS THAT THE LOWER THE
,TAR' AND NICOTINE CONTENT OF CIGARETTE
SMOKE, THE LESS HARMFUL WOULD BE THE
EFFECT'
PREFACE XII
THIS WAS FOLLOWED BY THE DECISION OF THE FEDERAL
TRADE
COMMISSION TO BEGIN MEASURING THE 'TAR' AND
NICOTINE YIELDS
OF CIGARETTES AND TO PERMIT MANUFACTURERS TO BEGIN
USING
THIS INFORMATION IN THEIR ADVERTISING.
THIS IN TURN TRIGGERED:
CHANGES IN CIGARETTE PRODUCTION TECHNOLOGY
DEVELOPMENT OF RECONSTITUTED TOBACCO
REFINEMENT OF CIGARETTE FILTERS AND PAPER
NEW TOBACCO STRAINS
TO MENTION A FEW-
THE OBJECTIVE WAS TO REDUCE THE 'TAR' AND NICOTINE
OF CIGARETTE SMOKE.
TH E IMPACT OF THESE CHANGES IS NOTED IN THE
FOREWORD
OF THE 1982 REPORT.
'THE HEALTH CONSEQUENCES OF SMOKING'
A REPORT OF tHE SURGEON GENERAL
Lower Tar Cigarettes
This report also notes that smokers who use
filtered or lower tar
cigarettes have statistically lower death rates
rrorn lung Cancer than
do cigarette smokers who use nonfiltered or higher
tar brands- This
reduced risk was also noted for laryngeal cancer.
However, cancer
death rates ror smokers of lower tar cigarettes
were still significantly
higher than those noted ror nonsmokers. --J
t--4
Edward N. Brandt. Jr-, M.D.
Assistant Secretary for Health 1`4
110
--j
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IN THE 1979 'SMOKING AND HEALTH A REPORT OF THE
SURGEON
GENERAL', JULIUS B. RICHMOND, M.D. STATES
Adhering to this spirit of inquiry and
re-cog-nizing the atagnitude of
the public health problem, we must ask: What is
'our ctirrent
knowledge about "appropriate remedial action?"
What scientific,
economic, and behavioral facts are important for
the design of public
policy toward cigarette smoking? What have we
learned so far, and
where do we go from here? To answer these
questions, we must
confront three central facts: Individuals vary in
their health risks
associated with cigai-eLte smoking. Individuals
vary in their cigaretti-
smoking behavior. The cigarette product itself is
changing.
vii
PREFACE VII
THE LAST SENTENCE 'THE CIGARETTE PRODUCT ITSELF IS
CHANGING'
LEADS TO THE THEME OF THIS PROJECT I.E. NOW DO WE
DESIGN
AND MANAGE FUTURE PRODUCT CHANGES?
THE NATIONAL CANCER INSTITUTE PORTION OF THE
"SMOKING
AND HEALTH A REPORT OF THE SURGEON GENERAL'
CONTAINS THEIR
THOUGHTS RELATIVE TO PRODUCT CHAkGE.
In this chapter we will consider the tobacco as a
raw material, how it
is made into cigarettes, the cigarette smoke
generation process, the
composition of cigarette smoke, physiological
responses to ciga4tte
:Moke, the pharmacology of nicotine as a component
of cigarette
moke, and efforts to define less hazardous
cigarettes through
cigarette smoke modification. Also, consideration
will be given to the
effects of smoke characteristics on smoking
behavior and, therefore, on
the dose inhaled by man and experimental animals.
14-9
THESE THOUGHTS WILL BE AMPLIFIED IN THE FOLLOWING
PARTS OF THIS REORT.
C7--)
--4
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A PARALLEL ACTIVITY IN THE FIELD OF SMOKING AND
HEALTH
WAS TAKING PLACE IN GREAT BRITAIN.
1 9 5 9
THE ROYAL COLLEGE OF PHYSICIANS OF LONDON SET UP A
COMMITTEE TO:
pREPORT ON THE QUESTION OF SMOKING
AND ATMOSPHERIC POLLUTION IN RELATION
To CARCINOMA OF THE LUNG AND OTHER
ILLNESSES'
AND HAD DIFFICULTY IN WORKING WITH TWO VARIABLES
SO THAT
IN:
1 9 6 2
THE FIRST REPORT 'SMOKJNG AND HEALTH' WAS
PUBLISHED.
9 7 1
THE SECOND REPORT BY THE ROYAL COLLEGE OF
PHYSICIANS
OF LONDON 'SMOKING AND HEALTH NOW' WAS PUBLISHED.
CHAPTER 3 OF THAT REPORT 'THE CHEMISTRY AND
PHARMACOLOGY
OF TOBACCO SMOKE' IDENTIFIES THE SUBSTANCES OF
MEDICAL
IMPORTANCE AND GROUPS THEM INTO FOUR MAIN GROUPS.
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a Known canctr-producing jubstances. Tlese are of
two kinds:
carcinogens or cancer initiators, which have been
3hbwa
by themselves to induce cancer in experimental
animals,
and co-carcinogem or cancer promoters, which do
not
themselves produce cancer but accelerate its
productioa
by cancer iaitiator3.
b Irritant Mttances. 'nese may stimulate secretion
of mucus
in the bronchial tubes and inhibit the action of
the cilia"
Uning them. Some of these irritants arc also
co-carcinogens.
c N-tcotine. This has a wide range of
pharmacological actions
oa tissues throughout the body, especially on the
nervous
system.
d Carbon'manoxide and atlurgases. Carbon monoxide
interferes
with the blood's capacity to carry oxygen or with
the use
of oxygen in the tissues. T'here are other
chemically active:
gases, including oxides of nitrogen and hydrogen
cyanide,
the effects of which in the low concentrations
occurring in
tobacco smoke are uncextain.
36 SOWkins wd Health Now
1 9 7 7
THE THIRD REPORT BY. THE ROYAL COLLEGE OF
PHYSICIANS
OF LONDON 'SMOKING OR HEALTH WAS PUBLISHED.
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PAGES 25 AND 26 OF THIS REPORT CONTAIN THE
FOLLOWING:
uss Harmful Smoking Habits
The tobacco manufacturers have been steadily
reducing the tar and nicotine
delivery of their cigarettes in recent years by
changing the tobacco Je2f
used, and by increasing the efficiency of filters.
Forty years ago. one of
the most pular cigarettes had tar and nicotine
yields of 36 and 3 -3 mg
respectiveFyo (3 0). If them figures were typical
for that period, average
yields were &1ready considered lower in 1965 when
mgular analyses were
started (Table 11). Since then. owing especially
to the large r*itch from
plain to rUter-tipped brands of cigarettes, there
his been a further striking
fill in the average amount of tar and nicotine to
which British smokers
expose themselves (Table 12).
Table IJ
Sal-weight.d A-rage Ta and Nicodne Y;cldj o(
CiP-tt.3 Sold in the UX 196S to 1975
Yew Mi.. Tar Mean Nicotine
YL-ld (m4) YzeLd (,,W)
1965 31.4 2.08
1967 26.0 1.92
1969 23.9 1.67
1971 21.3 1-51
1973 19.7 1.44
1975 17.9 1.33
Change 196S-7S -13.5 -0.73
% Change -43 - 3S
Figuits suppLied by the TRC
PACE 121, UNDER THE HEADING OF 'LESS HARMFUL
SMOKING,'
CONTAINS THE FOLLOWING:
Reducing the harmfu.1 constituents of cigarette
smoke. Since we do not
know precisely which of the many hundreds of
chernical compounds in
the smoke, of cigarettes are responsible for
cancers, bronchitis. emphysema.
or damage to the heart and blood vessels, we
cannot specify exactly what
constituents in the smoke should be reduced to
lessen the risk. But most
smoldrig-related cancers are probably caused by
carcinogenic substances
in the Iar' fraction of the smoke, and it has been
shown that A;nerican
smokers who for at least ten years have smoked
ordy filter-tipped cigar-
ettes (which have a lower tar delivery than plain
cigarettes) have their
risk of getting lung cancer almost halved (46). A
more recent, larger study
indicates that the risk is reduced by only sorne
20 per cent (I 5a).
U4
00
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1 9 8 3
ar HEALTH OR SMOKING.-
OF PHYSICIANS
FOLLOW-UP REPORT OF THE ROYAL COLLEGE
CHAPTER THREE PAGE 23
TABLE 3.1. Ch-ps in EngLand and Wales male lung
cancer death rates in early
middk age wince tar deliveries have been reduced
Ap at time Death rates per million men from
c,ancers of
of observation the respiratory tract, excluding
ILrynx
Men bom in about Men bom in about
1910. and observed 1930-1930. and Ratio
in 1940-1960 observed in 1980
30-34 39- 13 0.3
35-39 98.. 45 0.5
40-" 253- 134 0-5
45-49 5971* 378* 0.6
High mean tw intake only in rust decade at so of
smokLng history
High mean tar intake throughout smoking history
CHAPTER NINE PACE 87
L= dangerous fonm of smoking 7 97
Ownses in national lung cancer deaths
As pointed out earlier (Figure 3.1) there has been
an imporunt do~,.
ward trend in lung cancer mortality in men or all
ages in the United
Kingdom. In women this trend has been men only in
the youngest age
groups. In seeking an explanation for them trends
the influence of
smoking habits 20-30 years earlier his been shown
to be of paramount
importance (the 'generaLion effect').
There is no obvious explanation for these falls in
national lung cancer
death rates other than the changes in the tar
delivery of cigarettes.
Cigarette consumption per head did not begin to
fall in men until very
recently (see Figure 11.2). If the fall in lung
=ccr deaths is due to
smoking lower taF/nicotine cigarettes. complete
compensation for the
lower nicotine by increasing total smoke intake
cannot have been wide-
spread. Declining air pollution is unlikely to
have contributed much to
this effect since air pollution appears to have
little if any effect on lung
cancer incidence 1131, and moreover similar
decreases have been
observed in unpolluted Finland (13 1.
L14
CID
(:D
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CHAPTER FIVE OF 'HEALTH OR SMOKING' IS ENTITLED
SUSCEPTIBILITY TO SMOKING HAZARD' AND SOME OTHER
CONSIDERATIONS ARE BROUGHT INTO THE PICTURE.
GENETIC PREDISPOSITION
GENETIC FACTORS THAT MIGHT INFLUENCE
SUSCEPTIBI.LITY
TO SMOKING.
D I E T
FOR CANCER OF THE LUNG, THE EVIDENCE SO FAR
AVAILABLE SUGGESTS THAT LOW INTAKE OF VITAMIN A
INCREASES THE CHANCE THAT SMOKING WILL CAUSE
THIS CANCER.. STUDIES TO SEE WHETHER INCREASING
THE DIETARY INTAKE OF VITAMIN A CAN DECREASE
THE CARCINOGENIC EFFECTS OF CIGARETTE SMOKING
ARE NOW UNDER WAY.'
THESE TWO POINTS ARE INDICATIVE OF THE INCREASING
AWARENESS OF THE INTER-RELATIONSHIP OF LIFESTYLE,
DIET,
ENVIRONMENT, AND HEALTH.
CIGARETTE SMOKING IS ONE FACTOR AND MUCH HAS BEEN
DONE TO IDENTIFY TOXIC SMOKE COMPONENTS. INDUSTRY
HAS
REDUCED THE QUANTITY PER CIGARETTE THROUGH A 'TAR!
REDUCTION
PROGRAM. THE VALUE OF THIS CHANGE WAS IDENTIFIED
EARLIER.
CONTINUED GROSS REDUCTION OF 'TAR' TO &RING ABOUT
REDUCTION OF TOXIC COMPONENTS MAY LEAD TO AN
APPRECIABLE
ALTERATION OF THE ORGANOLEPTIC PROFILE AND
CONSEQUENTLY
TO CONSUMER REJECTION.
WHAT APPEARS TO BE A REASONABLE COURSE OF ACTION
IS
THE SELECTIVE REDUCTION OF SPECIFIC SMOKE
COMPONENTS TO
REDUCE THE SPECIFIC TOXICITY OF CIGARETTE SMOKE.
LA
C. WARREN SEPTEMBER 9, 1985 00
CD
L.-4
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THERE HAVE BEEN EXPRESSIONS OF CONCERN BY LAWYERS
THAT IF WE OVERTLY STATE THAT WE ARE ATTEMPTING TO
REMOVE
TOXIC AGE4TS IN THE GAS PHASE AND PARTICULATE
MATTER OF
CIGARETTE SMOKE THAT WE ARE ADMITTING GUILT IN
THE.SMOKING
AND HEALTH CONTROVERSY.
THIS IS NOT NECESSARILY SO. THE PROGRESSION FROM
TOXIC AGENT TO BIOLOGIC ACTIVITY IS DONE BY THE
SURGEON
GENERAL, WITH VARYING DEGREES OF CERTAINTY. FOR
EXAMPLE,
IN THE 1981 PUBLICATION
'THE HEALTH CONSEQUENCES OF SMOKING
THE CHANGING CIGARETTE
A REPORT OF THE SURGEON GENERAL'
ON PAGE 24, "RESEARCH NEEDS ON LOW-YIELD
CIGARETTES,' THERE
IS A LIST OF RESEARCH RECOMMENDATIONS AMONG WHICH
IS
0 Another research need is routine, frequent
surveillance of
current and future lower "tar" and nicotine
cigarettes, for
specific chemical constituents and biological
activity. In addition
to "tar," nicotine, and carbon monoxide yield. new
types of
cigarettes should be monitored regularly for
delivery of other
potentially harmful constituents, such as
benzo(a]pyrene, phe-
nols, catechols, nitrosamines, nitrogen oxides,
volatile aldehydes,
and radionuclides. More frequently updated ratings
of "tar,"
nicotine, and carbon monoxide content would permit
more
accurate studies on the potential impact of
cigarette oomponent3
on health.
co
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1 T WOULD BE REASONABLE FOR US TO SAY THAT WE DO
NOT
JEBATE THE BIOLOGICAL AND HENCE MEDICAL
INTERPRETATION
OF THE SPECIFIC CHEMICAL CONSTITUENTS, BUT TMAT
--,WE ARE
WORKING TOWARD REDUCING OR REMOVING THE TOXIC
AGENTS, AND
LET THE SURGEON GENERAL OR THE ROYAL COLLEGE OF
PHYSICIANS
DETERMINE WHATj IF ANY, ARE THE MEDICAL
IMPLICATIONS.
THIS, THEY HAVE ALREADY DONE, E.G. WHEN THEY LINK
REDUCED
'TAR' CONTENT OF CIGARETTE SMOKE AND DECLINING
INCIDENCE
OF LUNG CANCER.
THE APPROACH THAT WE REMOVE THE TOXIC AGENTS
IDENTIFIED
BY OTHERS IS COMMON PRACTICE E.G. WHEN THE F.D.A.
MAKES
A JUDGMENT IN THE AREAS OF
FOOD
PHARMACEUTICAL
BEVERAGE
I.E. REMOVES SOME COMPONENT FROM THE G.R.A.S.
LISTj THE
RESPONSE IN INDUSTRY IS AUTOMATIC.
WE COULD ASSUME THE SAME IMPLIED DIRECTIVE BY
TAKING
TABLE I AND TABLE 11 FROM THE 1981 SURGEON
GENERAL'S REPORT
'THE CHANGING CIGARETTE.' C::>
Nj
co
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TABLE L-btajur tuxic sigenLa In the gas phaw of
cigurette
anoke (unaged)"
Ag-L
wtmtr US
C-Vo
D.WATI-Al- C I-Ma .1 Is C
MTi.KbJ1.iU_ C 0.1-10 g 1.3 IkC
Dwdyt.Liu--- C O~10 g LS g
hr-pyrMidi- C Z-42 g 11
othw C a.-M
C 2" C 22 C
Vi.71 &W.,k C 1-16 .4 12 C
T1 WS g ID C
Cr. C.C 2D-20 pg 3D pg
816-g q-id. Cr, T ID-MQ pg 110 PC
Aa.i_ Cr 25-140 pg 70 pg
AM-W-h* Cr W1.4w og ODD pC
)r-.C- ..id- (No.), T 10-M pq 350 PC
A- T?- IDA50 pg 00 PC
pp,&_ V- $45 pC 10 PC
C.A.. Ki-k T 2-M at 17 ag
~~9~ ~Y Lim - wEb mum"= ft - WCkW awbanyL &W F=NNY
v46Mk ddwUmLsd Wfm
L.d -idl-
'C T1. -- iu--. C.C. .; CT. a. n. ft-,; d T. -.g-L
-b", fft. b.ab,
Is SEwh- fd bk"W US dg- b~ pH <L&. wW tbancf~ ~ md
pyndi~ ~ p-
-4 f~
8 DUWX wy.&. A
TABLE L-Major toxic agen ts in the pwtculate
matter of
eigamtte amoke (unaged)*
Ae- C._bb.Vdg_n.
9-0
mp-d U3
*p_U.0
g a ag
Ti t&Z 0.6 g
T1 5-0 to ,
T1 S-M ag 40 g
Oth. *Pd- -b~ hyd-
-W. (>M -1 T1 ?
DDAm(LJwAw T1 3-10 ag 8 g
DQ...K.A*rwi_ T1 ?
Dib .. T1 al 0.7 g
py-
C.C
50-w0 L
'9 g
Fla.-th- C.C SD-za ag 170 g
5--U.hJ1P-7k- c4c 10-0 g 30 Mg
oLh. p.10.6- -1. 17~b_
-b- Wo Now-low C.C T
4.0th.k" GIC 1-10 PC
G.C 0343 g OA .6
C.C Q005412 41 mg
Othw ambw _p=0& C.C ? ?
Ousebol C.C 40-M PC
3- A 4-Kthy~ C.C jig 32 PC
00- -&-b*6 (>4 wmp-UWO C.C ?
U.k.- Ud i6 C.C 7 7
C 100.-250 g 250 C
Oth. -6t5. U-- C ? ?
".phthyl-im DC " g a Ag
ot- -,;. -i- 9C T ?
UA__ it'. DC ?
pw0ai-no C 0.03-13 pa
Nidw W.PDU=6 C 13-aw ag I
C.d.i.. C 9-10 .6 1
A-.k C 1-26 pg ?
Ni.d. T 0.1-2.0 ot LA ag
vi- Lb.0 T 0.0142 mg U me
ph-W Cr M-we pg as pg
-P--&) CT 10- L50 10
c d_... W.~ T1. U.- _t1._. C.C. ft - %_U w T.
Uzk.g-L
'S - de..U. ta. dp b-CM Q. p_ MM
souwa Wyd. .4 sdh- ('a^
C)
__J
c0
CZ)
(ON
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-3-
IN THIS CASE, WE WOULD USE ONLY THE 'AGENT' COLUMN
SINCE THE 'BIOLOGIC ACTIVITY' BELOAGS TO THE
SURGEON GENERAL.
THE STATED OBJECTIVE COULD BE:
CIGARETTE AND SMOKE, CHEMISTRY MODIFICATION
C. WARREN
SEPTEMBER 12, 1985
C=)
--`j
(-P4
-r-lz- -
U-4
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