ADDITIONAL TESTS Ignition Propensity Testing Toxicity Assays

IGNITION PROPENSITY TESTING Cigarettes of every brand manufactured on or after October 1, 2005 shall burn their full length no more than 25% of the time when tested according to the Test Method specified Testing to be performed on 10 layers of filter paper using ASTM International method E2187 — 04, dated July 1, 2004 and entitled Standard Test Method for Measuring the Ignition Strength of Cigarettes

IGNITION PROPENSITY TESTING

TOXICITY TESTING Generate the smoke and collect it Then use the smoke condensate to perform some tests in the laboratory

TOXICITY 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 BIOLOGY Cell Nucleus Chromosomes DNA Proteins

BUILDING THE BETTER MOUSETRAP CIGARETTE

THE LESS HARMFUL CIGARETTE

DILUTION IS THE SOLUTION TO POLLUTION

BLOWING SMOKE

IT’S ONLY AIR

A QUICK RECAP WE HAVE LEARNED THE FOLLOWING: –HOW TO DESIGN A CIGARETTE –HOW TO MANUFACTURE A CIGARETTE –HOW TO TEST A CIGARETTE BUT

WHAT DOES IT ALL MEAN?

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

THE LAST WORD The only safe cigarette is an unlit cigarette

THE FTC TEST METHOD The Commission's test method was not designed "to determine the amount of 'tar' and nicotine inhaled by any human smoker, but rather to determine the amount of tar and nicotine generated when a cigarette is smoked by a machine in accordance with the prescribed method.“ The purpose of the program was to provide smokers seeking to switch to lower tar cigarettes with a single, standardized measurement with which to choose among the existing brands. This goal was consistent with the then-consensus of the scientific community that lower tar and nicotine cigarettes should be less harmful than higher tar and nicotine brands. FEDERAL TRADE COMMISSION CIGARETTE TESTING Request for Public Comment ( FTC Press Release -- Statement of Considerations 2 (Aug. 1, 1967).

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

THE LATEST FROM ISO The International Standards Organization (ISO) TC126 has recently recognized this misuse of machine measured yields and submitted for a formal vote a resolution adopting as a rationale for all machine smoking testing standards the following statement: – No machine smoking regime can represent all human smoking behaviors; – Methods are recommended which test the product under conditions of different intensities of machine smoking testing in order to collect main stream smoke; – Machine smoking testing is useful to characterize cigarette emissions for design and regulatory purposes, but communication of machine measurements to smokers can result in misunderstanding about differences in exposure and risk across brands; – 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 valid measures of human exposure or risks. Communicating differences between products in machine measurements as differences in exposure or risk is a misuse of testing using ISO standards.

THERE IS NO STANDARD HUMAN Product Smoker Interaction Output from the cigarette (aka Delivery) Intake by the smoker Uptake what gets absorbed in the body

THERE IS NO STANDARD CIGARETTE

CAUTION Product testing does not report the true delivery of the product to the smoker Product testing does not provide an accurate, or reasonable, estimate of the smoker’s exposure or risk