PHILIP MORRIS

USA INC.

OPERATIONS CENTER, RICHMOND, VIRGINIA 23261-6583

March 23, 2006

John L. Pauly, Ph.D.

Department of Immunology
Roswell Park Cancer Institute
Elm and Carlton Streets
Buffalo, NY 14263

Dear Dr. Pauly:

As we continue our ongoing scientific dialog on filter fibers and particles, it is important to
build on past scientific discussions we have had with you. In addressing your most
recent letter on Charcoal filters, Carbon/Charcoal Fall-out, SCoR, Marlboro UltraSmooth,
and Lark"’, I refer you to a presentation on Estimation of Added Risk Associated with
Carbon Inhalation’ which was given to you along with a copy on June 14, 2004 at PM
USA in Richmond, VA.

As part of that presentation we discussed your two publications (slide 5, titled

Publications Concerning Particle Transfer) which you referenced in your recent letter.
The data presented to you on June 14, 2004 (slide 9, titled Particle Counts) are the
same data, with the exception of the addition of data on Marlboro UltraSmooth test
market products, that were presented to you at the Massachusetts Department of Public
Health (MDPH) meeting in Boston, MA, on February 7, 2005 (slide 16, titled "SCoR:
Carbon Filter Market Evaluation).

At the presentation on June 14, 2004, we indicated that an extreme case study design
(i.e., dry puffing using 12 unlit 55 ml puffs) was used to estimate potential particle
transfer. There is a reasonable expectation that these particle counts are even lower
under actual smoking conditions as the filter becomes wet due to trapped tar. The actual
transfer during smoking is unknown because currently there is no scientific method to
differentiate between specific particle types (e.g., carbon particles and the rest of the
particulate phase) under smoking conditions. "Based on conservative estimates of
potential exposure and hazard, the added risk from potential carbon inhalation from
cigarette filters is negligible." (slide 17, titled "Summary").

We presented the data on particle transfer with the additional results of Marlboro
UltraSmooth test market products at the MDPH meeting in an effort to continue our
scientific dialog with you in the context of our previous presentation to you on the
estimation of added risk associated with carbon. We remain interested in your
perspective of the total particle counts of 100 or less for the brands including Marlboro
UltraSmooth with carbon-on-tow filters (slide 16, titled "SCoR: Carbon Filter Market
Evaluation).

Letter from John L. Pauly, Ph.D. Roswell Park Cancer Institute to Denise F. Keane PM USA, dated January 6, 2006.
During the MDPH meeting, we focused our discussion on carbon filter technologies.
Carbon filtration is one of several technologies that we are exploring for their potential to
reduce a smokers exposure to harmful compounds in cigarette smoke. "Gas phase
constituents dominate both [the theoretical] cancer risk index and [the theoretical] non-
cancer risk index for cigarette smoke. The contribution of 1,3-butadiene to [the
theoretical] cancer risk index was more than twice that of the next highest contributing
carcinogen (acrylonitrile) using potencies from the State of California EPA." "Acrolein and
acetaldehyde greatly outweigh the remaining compounds in regard to the contribution to
respiratory irritation" (Fowles and Dybing, Tobacco Control 12:424-430, 2003). We
presented results on Marlboro UltraSmooth test market products of reductions in 1,3
butadiene, acetaldehyde, acrolein, benzene, and acrylonitrile (gas/vapor phase
constituents) compared to a Marlboro Ultra Lights control data set.

We plan to submit a publication that presents the risk assessment of particle transfer in
the context of the potential reductions in certain gas vapor phase smoke constituents
resulting from carbon filtration. We reserve the right to publish our data in its entirety as
originally presented to you including the data on carbon-on-tow and Marlboro
UltraSmooth. You may however summarize but not publish our data in Figure 1 (ibid, pg.
1). In the presentation of June 14, 2004, you will find information on brands, the protocol,
and our data on particle transfer for both carbon-on-tow and cavity (i.e., plug-space-plug)
filters of which you show only the results for cavity filters in Figure 1 (ibid, pg. 1). The
citation would be properly acknowledged as a private communication with PM USA on
June 14, 2004.

Following the Philip Morris USA Guidelines for the Evaluation of Ingredients, Materials,
Processes and Product Designs we have evaluated the components, including the
flavors and flavor thread, and the carbon filter technology used in the Marlboro
UltraSmooth test market products. The objective of this pre-market toxicological
evaluation is to assure that new (i) ingredients, (ii) materials, (iii) processes, and (iv)
product designs would not be reasonably expected to increase the inherent toxicity of
cigarette smoke. This evaluation is consistent with the Institute of Medicine regulatory
principle 7, i.e., In the absence of any claim of reduced exposure or reduced risk,
manufacturers of tobacco products should be permitted to market new products or modify
existing products without prior approval of the regulatory agency after informing the
agency of the composition of the product and certifying that the product could not
reasonably be expected to increase the risk of cancer, heart disease, pulmonary disease,
adverse reproductive effects or other adverse health effects, compared to similar
conventional tobacco products, as judged on the basis of the most current toxicological
and epidemiological information . 2 We presented information on the objective, scope,
and methodology (i.e., giving examples) of the toxicological acceptability testing at the
MDPH meeting in Boston in 2005 (slides 6, 7, and 8 of SCoR Program: Carbon Filter
Technology). A description of PM USA guidelines is available to the scientists and public
health community at www.omusa-science.com .

As stated by the International Agency for Research on Cancer (IARC) Working Group on
the Evaluation of Carcinogenic Risks to Humans [n]evertheless, after considering the
limitations of the evidence, the Working Group concluded that changes in cigarettes
[which have included cellulose acetate filters] since the 1950s have probably tended to
reduce the risk for lung cancer associated with the smoking of particular numbers of
cigarettes at particular ages." (IARC Monographs on the Evaluation of Carcinogenic
Risks to Humans, Volume 83, Tobacco Smoke and Involuntary Smoking, Lyon, France,
2004, pg. 171). Consider this potential of reduced risk for filter cigarettes in the context of
the negligible risk of CA fibers. PMUSA and external scientists have concluded that the
probability for the deposition of CA fibers in human lungs is very low and therefore no

2
Stratton, K.; Shetty, P.; Wallace, R.; Bondurant, S., eds. Clearing the smoke: Assessing the science basefor tobacco harm reduction.
National Institutes of Health, Institute of Medicine, Washington, D.C.: National Academies Press; 2001
significant risk from those fibers in addition to the risks from smoking cigarettes without
such fibers is expected (slide 15, titled Risk of presentation on Evaluation of Fiber
Fallout from Cigarettes with Filters Containing Cellulose Acetate, meeting on June 14,
2004).

Please give me a call if you have any additional questions.

Sincerely,

Kenneth F. Podraza, Ph.D.

Vice President
Philip Morris USA, RD&E
P. 0. Box 26603
Richmond, Virginia 23261
804-274-5855, Ken.F.Podraza@pmusa.com

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John L. Pauly, Ph.D.

Department of Immunology
Roswell Park Cancer Institute
Elm and Canton Streets
Buffalo, NY 14263