Product Design
9TH Meeting Technical Advisory Group Fire-Safe Cigarette Act of 1990 (900000).
Abstract
The Fire Safe Cigarette Act of 1990 required CPSC to develop information on smoke toxicity of low ignition potential cigarettes. In this document, different doctors describe what research will be done. Different areas include: changes in topography, inhalation and coviolent biological effects of tobacco smoke; cigarette smoke and toxicity; Toxicity testing; Toxic smoke constituents and bioacidity for carcinogenicity; and smoking machine parameters. The trasncript seems to be incomplete.
Fields
- Author
- Adams
- Alderson Reporting
- Burns, D.
- Gairola, G.
- Gann, R.
- Gerard
- Harris, J.
- Hoebel, J.
- Hoffman, D.
- Lee, B.
- Mcgibeny
- Mcguire
- Pillsbury, H.
- Press, E.
- Shopland, D.
- Spears
- Townsend, D.E.
- Wilkenfeld
- Hypothesis
- Health effectsDesign changes which have measurably altered health effects of cigarette smoke, both for smokers and nonsmokers.
- Introduction of new/unconventional productsResearch and development of novel nicotine delivery devices and experimental tobacco designs.
- Mainstream constituent yieldsModification of selected mainstream smoke constituents in response to health concerns.
- Measuring human smoking behaviorMeasuring the effects of changes in human smoking behavior on intake of nicotine and smoke constituents.
- Measuring overall toxicityDevelopment of scientifically valid protocols and methods for testing the health and toxicity effects of changes in product design.
- Sidestream constituent yieldsModification of selected sidestream smoke constituents in response to health concerns.
- Smoke constituent testingDevelopment of methods for measurement of gas and particulate yields in mainstream and sidestream smoke.
- Toxicity and consumer intakeDevelopment of scientifically valid procedures for measuring biological activity and neurological effects of nicotine and smoke constituents.
- Keyword
- Ignition potential (IP)
- Puff interval (Time between puffs)
- Toxicity
- Carcinogenic (Cancer-causing)
- Teratogenic
- Additive
- Isopropanol
- Smoke Constituent
- Benzo(a)pyrene
- N-nitrosamines
- Nitric oxides
- Hydrocarbons
- Benzene
- Aldehydes
- NNK (4-Methylnitrosamino-1-(3-pyridyl)-1-butanone)
- NNAL
- Cotinine
- Design Component
- Burley tobacco
- Flue-cured tobacco
- Named Organization
- TAG
- International Agency for Research on Cancer
- CPSC
- NCI
- Oak Ridge National Lab
- FTC
- American Journal of Public Health
- NIST
- Technology/Method
- Ames assay
- Bioassays
- Brand
- Camel (RJR)
- More
- Marlboro (PM)
- Mystic
- Capri (PM)
- Subject
- Fire Safe Cigarettes (Products)
- Burn Rate (Design)
- Pressure Drop (Design)
- nicotine technology
- Transfer to Smoke (Measures)
- Smoke Delivery/Transport (Measures)
- Smoke Constituents
- Puff Count (Measures)
- Test/Inhalation (Testing)
- Test/Smoking Behavior (Testing)
- Test/Smoke Machine (Testing)
- Test/Animal Subject (Testing)
- Test/Smoke Constituents (Testing)
- Test/Toxicity (Testing)
- Secondhand Smoke/Toxicity
- Secondhand Smoke/Constituents
- Tobacco Weight (Design)
- Tobacco Type (Design)
- Density (Design)
Document Images
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1 9TH MEETING
2 TECHNICAL ADVISORY GROUP
3 FIRE-SAFE CIGARETTE ACT OF 1990
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6 Friday, January 29, 1993
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11 Room 332
12 600 Pennsylvania Avenue, N.W.
13 Washington, D.C.
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1 P R 0 C E E D I N G S
2 (9:05 a.m.)
3 MR. GANN: Let's start. Brian, it's yours.
4 MR. LEE: This starts the presentation of the
5 Health Tex plan part of this meeting, and briefly, I'm
6 going to go through about four or five different parts.
7 Let me just hit the headlines.
8 First, I will talk a little bit about the
9 history of why we have this plan. We will present the
10 expert panel who wrote the plan. We will talk about
11 what's in the plan. We will have a section for discussion
12 of the TAG members after the presentation, and then we
13 will ask a little bit about suggestions from the TAG as to
14 what to do with the remaining funds.
15 First, a little bit of background before we get
16 going. The Fire Safe Cigarette Act of 1990 required CPSC,
17 in consultation with HHS, to develop information on the
18 resultant effects of smoke from the low-emission
19 potential cigarettes. Now, this expresses a concern for
20 the possible adverse health effects of log emission
21 potential cigarettes on national health. The major
22 concern is that a small increase in the risk of toxicity
23 of these cigarettes might result in a large increase in
24 human toxicity. If this occurred, the toxicity might
25 offset the benefits that might be achieved from the
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1 reduction of fires.
2 The data needed to assess the health effects for
3 low emission potential cigarettes is nonexistent or
4 unavailable. This data must be developed by premarket
5 testing. However, there are two major limitations to this
6 testing, and these limitations have already been
7 acknowledged. One is that $50,000 was allotted by the
8 Act, and the TAG agreed that this amount precluded any
9 significant amount of toxicity testing. And two, there
10 are no standard guidelines that exist as to which test and
11 method should be used beyond what the FTC already requires
12 for a measurement of smoke, smoke tar, and nicotine.
13 Therefore, CPSC's staff, with HHS and the
14 concurrence of the TAG, decided that a plan must be
15 created to direct and guide the testing. CPSC convened an
16 expert panel to assist in the development of this plan.
17 The panel was composed of cigarette toxicity and testing
18 experts. These are knowledgeable scientists in the field,
19 and I would like to introduce the panel. I will go in
20 alphabetical order.
21 Doctor David Burns from the University of
22 California at San Diego, professor of medicine, who wrote
23 Chapter C, which is assessing changes in topography,
24 inhalation, coviolent biological effects of tobacco smoke
25 in humans.
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1 Doctor Gary Gairola, Tobacco and Health Research
2 Institute, University of Kentucky at Lexington. An
3 associate professor of pharmacology and experimental
4 therapeutics, he wrote Chapter E, which is the short term
5 test for the evaluation of cigarette smoke and toxicity.
6 Doctor Jeffrey Harris, who has not yet arrived,
7 who's from Internal Medicine Associates at Massachusetts
8 General Hospital, and is also a professor at the
9 Massachusetts Institute of Technology. He wrote Chapter
10 A, which is the overview and major considerations in the
11 toxicity testing of low emission potential cigarettes.
12 Doctor Detrich Hoffman from the American Health
13 Foundation, associate director and chief of environmental
14 carcinogenesis wrote two chapters, Chapter D-- analysis
15 of toxic smoke constituents -- and Chapter F-- in vivo
16 bioacidity for carcinogenicity.
17 Mister Harold Pillsbury, cigarette testing
18 consultant, wrote Chapter B, the smoking machine
19 parameters for collection of total particulate matter and
20 gases from low admission potential cigarettes.
21 This plan was created in consultation with
22 Doctor Donald Shopland, a TAG member from the U.S.
23 Department of Health and Human Services, NIH National
24 Cancer Institute, who is the coordinator of the smoke and
25 tobacco program.
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1 I would also like to acknowledge the technical
2 review and assistance of the following CPSC staff in the
3 directorate for health sciences: Doctor Lakshami Mishra,
4 senior toxicologist; Doctor Murray Cohn who is not here,
5 who is the division director of health effects, and Mr.
6 Jim Hoebel, who is the acting AED, the directorate for
7 health sciences. And he will be back.
8 Oh! Here he is. He is actually at my back.
9 (Laughter.)
10 MR. LEE: The plan discusses significant issues
11 and recommends a testing plan necessary for a broad
12 assessment of health effects. It's not intended to be a
13 detailed manual of health effects. It's not -- it is,
14 rather, intended to be a guide, not to explore every
15 single possible health effect, but to provide guidance for
16 the development of the needed data.
17 The chapter components of the plan will now be
18 presented by the cigarette toxicity and testing experts.
19 The expert panel each will speak for about 15 minutes or
20 so on their chapters, and then afterwards I will conclude
21 with an outline of the plan. During the presentations, I
22 will allow a few quick requests for instant
23 clarifications; however, in the interests of time, I would
24 like you to hold questions and comments for the discussion
25 period, which will be after all the presentations have
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1 been completed.
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The FTC method is the beginning basis for our
3 actual. toxicity testing. It defines some of the
4 mechanical parameters for the generation of the smoke
5 constituents. These will be described by Mr. Harold
6 Pillsbury.
7 MR. PILLSBURY: I guess I get to start off
8 first, this morning. The method as described in Chapter B
9 there, which is basically the same method that Federal
10 Trade Commission has been using since 1967, I guess it
11 was, and has been increased and we are now doing -- having
12 the carbon monoxide done in addition to the tar and
13 nicotine.
14 The smoking machine that is recommended or that
15 I would recommend would be the 20-port smoker, which is
16 one similar to the one Filtrona put out which differed
17 from the one that was used by Federal Trade in so much as
18 the Federal Trade machine analyzed the gasses from the
19 cigarette on a puff-by-puff basis. After they were passed
20 through a filter to collect the tar.
21 The Filtrona machine -- the Filtrona 400 which
22 is in production now and being used, and being used by the
23 tobacco institute laboratory -- collects the gasses in a
24 bag, and after all the cigarettes have been smoked then
25 it's passed through an IR detector to determine carbon
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1 monoxide.
2 There would be a problem with passing the gasses
3 from a bag through an IR detector for the determination of
4 the oxides or nitrogen or some other gasses that might be
5 there because of the aging in the bag. So a modification.
6 to the machine could be made without changing the method
7 for the determination of a gas machine.
8 Cigarettes that are smoked should be in an
9 environmental room, should be kept in an environmental
10 room, so that they maintain their fresh condition during
11 the smoking as well as prior to the smoking. The but
12 length should be marked to a 23 millimeter but length for
13 the overwrap plus 3 millimeters, which is what Federal
14 Trade has used. I think the industry is using all the way
15 through.
16 Cigarettes do not necessarily have to be done by
17 weight. We never did weight selection. We did visual
18 selection because most people when they pull a cigarette
19 out or a pack use the cigarette that comes out provided
20 it's not seriously damage. So weight selection should not
21 really be used unless there is some real drastic need for
22 it.
23 Cigarettes should be smoked to their butt
24 length. We smoke approximately 5 cigarettes to a pad, so
25 that they don't wet through and you lose some of your
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1 total particulate matter there.
2 After the cigarettes have been smoked, the pads
3 are to be extracted with solution, isopropyl --
4 isopropanol, into which a standard has been added for your
5 nicotine and a standard added for the water. They are an
6 internal standard so that you have a known point to make
7 your measurements from.
8 These solutions are then injected into a gas
9 chromatograph for the determination of the water that was
10 picked up on the filter pad and there was a determination
11 that nicotine.
12 The temperature of the oven can be varied to a
13 certain extent, depending on how the laboratory figures
14 their results come out best. There's no hard and set
15 absolute indication as to what the temperature should be
16 in these ovens.
17 The number of cigarettes to be smoked should be
18 at least 150 cigarettes. These cigarettes should be
19 randomly selected so that you're not picking any specific
20 characteristic.
21 On a smoking machine, there should be at least
22 four monitors for each run. That's to make sure that your
23 machine is operating right. Now, a monitored cigarette
24 doesn't necessarily have to be a cigarette made
25 specifically for this type of test. It can be any
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1 cigarette in which you have a tremendous history of what
2 the tar, nicotine, CO values are, and from that you can
3 determine whether the machine is operating off cant or
4 whether you get some variations in there that you don't
5 really need.
6 The results are there. The machine that is
7 presently being made by Filtrona does have room inside the
8 hood to which other tracks can be added, such as a hole
9 trap or a solvent trap or something like that for
10 determining other gasses that might be coming through.
11 Those traps should be kept below the burning level of the
12 cigarette.
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The data from 150 cigarettes would give you a
pretty good standard deviation and a pretty good
information as to what you were getting off of the
16 cigarette.
17 That's about all I have.
18 MR. LEE: I thank you, Mr. Pillsbury. Are there
19 any quick questions? If not we will move on.
20 Now, when we looked at developing the plan, the
21 major considerations for the potential adverse health
22 effects and the body of literature that we had to go on
23 was related to he toxicity of cigarettes that exist in the
24 market or existed in the market. Doctor Jeffrey Harris
25 will present an overview and major considerations in the
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1 toxicity testing of low-emission potential cigarettes now.
2 Dr. Harris?
3 DR. HARRIS: Thank you.
4 At the present time, the only governmentally
5 mandated health-oriented testing of commercially available
6 cigarettes is the measurement and reporting of tar and
7 nicotine and carbon monoxide in the mainstream smoke of
8 cigarettes by or through the method of the Federal Trade
9 Commission as described by Mr. Pillsbury. I'd just like
10 to stop for one second and ask Mr. Pillsbury if he recalls
11 how many different brands of cigarettes -- not families,
12 but individual brands, are now being tested by the most
13 recent FTC report?
14 MR. PILLSBURY: It's in the vicinity of 500.
15 DR. HARRIS: About 3 years ago, how many would
16 it be? 3 or 4, just as a ballpark.
17 MR. PILLSBURY: Maybe 200 to 300.
18 DR. HARRIS: That was my guess on the airplane.
19 With that exception, none of the toxicity tests
20 which are described in the report which you have received
21 are routinely reported or performed, at least in public,
22 on any cigarettes, whether they be experimental or
23 commercial.
24 Cigarette smoke -- both mainstream and
25 sidestream cigarette smoke are complex chemical mixtures.
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