ADDITIONAL TESTSADDITIONAL TESTS

Ignition Propensity Testing Ignition Propensity Testing

Toxicity Assays Toxicity Assays

IGNITION PROPENSITY TESTINGIGNITION PROPENSITY TESTING

Cigarettes of every brand manufactured on or after Cigarettes of every brand manufactured on or after October 1, 2005 shall burn their full length no more than October 1, 2005 shall burn their full length no more than 25% of the time when tested according to the Test 25% of the time when tested according to the Test Method specified Method specified

Testing to be performed on 10 layers of filter paper using Testing to be performed on 10 layers of filter paper using ASTM International method E2187 — 04, dated July 1, ASTM International method E2187 — 04, dated July 1, 2004 and entitled 2004 and entitled Standard Test Method for Measuring Standard Test Method for Measuring the Ignition Strength of Cigarettesthe Ignition Strength of Cigarettes

IGNITION PROPENSITY TESTINGIGNITION PROPENSITY TESTING

TOXICITY TESTINGTOXICITY TESTING

Generate the smoke and collect it

Then use the smoke condensate to perform

some tests in the laboratory

TOXICITY TESTSTOXICITY TESTS

Assay

Ames’ Assay(mutagenicity)

Neutral Red (cytotoxicity)

Micronucleus Assay

(clastogenicity)

Looks for

Mutations (changes) in DNA

Cell viability / is agent toxic to cells

Structural changes in chromosomes

SOME BASICS OF CELL BIOLOGYSOME BASICS OF CELL BIOLOGY

Cell

Nucleus

ChromosomesChromosomes

DNA

Proteins

BUILDING THE BETTER BUILDING THE BETTER MOUSETRAP MOUSETRAP CIGARETTECIGARETTE

THE LESS HARMFUL CIGARETTETHE LESS HARMFUL CIGARETTE

DILUTION IS THE SOLUTION TO DILUTION IS THE SOLUTION TO POLLUTIONPOLLUTION

BLOWING SMOKEBLOWING SMOKE

IT’S ONLY AIRIT’S ONLY AIR

A QUICK RECAPA QUICK RECAP

WE HAVE LEARNED THE FOLLOWING:WE HAVE LEARNED THE FOLLOWING:

– HOW TO DESIGN A CIGARETTEHOW TO DESIGN A CIGARETTE– HOW TO MANUFACTURE A CIGARETTEHOW TO MANUFACTURE A CIGARETTE– HOW TO TEST A CIGARETTEHOW TO TEST A CIGARETTE

BUTBUT

WHAT DOES IT ALL MEAN?WHAT DOES IT ALL MEAN?

CIGARETTE SMOKE IS TOXICCIGARETTE SMOKE IS TOXIC

Toxicity of cigarette smoke is a function of various Toxicity of cigarette smoke is a function of various elements such as:elements such as:Nature and amount of toxic emissions present in Nature and amount of toxic emissions present in smokesmokeDosage to the smoker – how much is the smoker Dosage to the smoker – how much is the smoker taking in (depends on how the product is smoked) taking in (depends on how the product is smoked) frequency and duration of use (including smoke frequency and duration of use (including smoke topography) topography) Smoker’s absorption, metabolism, genetics, other risk Smoker’s absorption, metabolism, genetics, other risk or protective factors, etc. (50 % smokers die of other or protective factors, etc. (50 % smokers die of other causes)causes)

THE LAST WORDTHE LAST WORD

The only safe cigarette is an unlit cigaretteThe only safe cigarette is an unlit cigarette

THE FTC TEST METHODTHE FTC TEST METHOD

The Commission's test method was not designed "to determine The Commission's test method was not designed "to determine the amount of 'tar' and nicotine inhaled by any human smoker, the amount of 'tar' and nicotine inhaled by any human smoker, but rather to determine the amount of tar and nicotine but rather to determine the amount of tar and nicotine generated when a cigarette is smoked by a machine in generated when a cigarette is smoked by a machine in accordance with the prescribed method.“accordance with the prescribed method.“ The purpose of the The purpose of the program was to provide smokers seeking to switch to lower tar program was to provide smokers seeking to switch to lower tar cigarettes with a single, standardized measurement with which to cigarettes with a single, standardized measurement with which to choose among the existing brands. This goal was consistent with choose among the existing brands. This goal was consistent with the then-consensus of the scientific community that lower tar and the then-consensus of the scientific community that lower tar and nicotine cigarettes should be less harmful than higher tar and nicotine cigarettes should be less harmful than higher tar and nicotine brands.nicotine brands.

FEDERAL TRADE COMMISSION CIGARETTE TESTING Request for Public Comment (http://www.ftc.gov/os/1997/09/cigtest.htm#N_6_)

FTC Press Release -- Statement of Considerations 2 (Aug. 1,

1967).

WHAT USE ARE SMOKING MACHINES?WHAT USE ARE SMOKING MACHINES?

Provide an indication of the engineering of the product (e.g. degree of Provide an indication of the engineering of the product (e.g. degree of ventilation) / quality control for industry ventilation) / quality control for industry The machine results are not necessarily predictive of yields created by The machine results are not necessarily predictive of yields created by individual consumers. individual consumers. A standard smoking method representing all smokers and conditions is A standard smoking method representing all smokers and conditions is impossible. impossible. The Canadian Modified smoking conditions provide an upper yield measure The Canadian Modified smoking conditions provide an upper yield measure (combined with ISO smoking conditions, provides a range of what is available (combined with ISO smoking conditions, provides a range of what is available to the smoker, depending on how the product is smoked). to the smoker, depending on how the product is smoked). Provide researchers with assurance that smokers’ risk is independent of tar Provide researchers with assurance that smokers’ risk is independent of tar delivery, except for highly ventilated productsdelivery, except for highly ventilated productsInform researchers that different cigarettes with identical values are differentInform researchers that different cigarettes with identical values are different

THE LATEST FROM ISOTHE LATEST FROM ISO

The International Standards Organization (ISO) TC126 has recently The International Standards Organization (ISO) TC126 has recently recognized this misuse of machine measured yields and submitted for a recognized this misuse of machine measured yields and submitted for a formal vote a resolution adopting as a rationale for all machine smoking formal vote a resolution adopting as a rationale for all machine smoking testing standards the following statement:testing standards the following statement:

– – No machine smoking regime can represent all human smoking behaviors;No machine smoking regime can represent all human smoking behaviors;– – Methods are recommended which test the product under conditions of Methods are recommended which test the product under conditions of

different intensities of machine smoking testing in order to collect main different intensities of machine smoking testing in order to collect main stream smoke;stream smoke;

– – Machine smoking testing is useful to characterize cigarette emissions for Machine smoking testing is useful to characterize cigarette emissions for design and regulatory purposes, but communication of machine design and regulatory purposes, but communication of machine measurements to smokers can result in misunderstanding about differences measurements to smokers can result in misunderstanding about differences in exposure and risk across brands;in exposure and risk across brands;

– – Smoke emission data from machine measurements may be used as inputs Smoke emission data from machine measurements may be used as inputs for product hazard assessment, but they are not intended to be nor are they for product hazard assessment, but they are not intended to be nor are they valid measures of human exposure or risks. Communicating differences valid measures of human exposure or risks. Communicating differences between products in machine measurements as differences in exposure or between products in machine measurements as differences in exposure or risk is a misuse of testing using ISO standards. risk is a misuse of testing using ISO standards.

THERE IS NO STANDARD HUMANTHERE IS NO STANDARD HUMAN

Product Smoker Interaction

Output from the cigarette

(aka Delivery)

Intake by the smoker

Uptake what gets absorbed in the body

0

5

10

15

20

25

30

35

40

45

0 5 10 15 20 25 30 35 40 45

Pack Value (mg)

Mea

sure

d V

alu

e (m

g)

ISO (02-03) INT (02-03) ISO (03-04) INT (03-04) ISO (04-05) INT (04-05)

THERE IS NO STANDARD CIGARETTETHERE IS NO STANDARD CIGARETTE

CAUTIONCAUTION

Product testing does not report the true Product testing does not report the true delivery of the product to the smoker delivery of the product to the smoker

Product testing does not provide an Product testing does not provide an accurate, or reasonable, estimate of the accurate, or reasonable, estimate of the smoker’s exposure or risksmoker’s exposure or risk