Draft Correspondence Concerning A Regulatory Matter Prepared by Outside Legal Counsel to Tobacco Companies, Transmitted to in-House Legal Counsel to RJR and Other Tobacco Companies and Outside Legal Counsel to Tobacco Companies, Copied to TI Employee, Providing Confidential Information to Assist in the Rendering of Legal Advice.
Date: 29 Sep 1976
Length: 8 pages
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Length: 8 pages
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- Topol, A.J.
- Covington Burling
- Pepples, E.
- Greer, J.
- Stevens, A.J.
- Ahrensfeld, Thomas F. (PM General Counsel & Sr. VP, TI Executive Committee)TI Executive committee
- Hetsko, C.F.
- Kornegay, H.R.
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9/29/76 Q. Russell Hatchl, Esquire Federal Trade Commission Washington, D.C. 20580 Dear Mr. Hatchl:. This letter is being submitted to you in response to your letters of July 14, 1976, tothe General Counsels of American Brands, Inc., Brown & Williamson Tobacco Company, Liggett & Myers Inc., Lorillard, Philip Morris Incorporated, and R. J. Reynolds Tobacco Company. Your letters of July 14,.1976 stated that the Commission was giving consideration to testing cigarette sm6ke forcarbon monoxide content, in addition to the current test fo~ "tar" and nicotine content, and you invited each of the six com- panies to provide any input which.they may wish to make to the Federal Trade Commission in connection with consideration of carbon monoxide testing. At the outset we wish.to emphasize that no factual scientific data exists as to the relevance of carbon monoxide content in cigarette smoke in terms of health. Nor is there any evidence from which it can be concluded that the carbon monoxide content of cigarettes is of significance to consumers in making decisions relating to purchase of cigarettes. Indeed
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- 2 - we would like explicitly to reserve the.right to present before the Commission at the appropriate time and0pportunity a more detailed statement of our position as to the basic- lack of relevancy of testing for carbon monoxide content. Notwithstanding these observations, the six companies who received your letters of July 14, 1976, appreciate the opportunity to provide their input with regard .to the Com- mission's consideration of a methodology for carbonmonoxide testing. In approaching this issue, the Commission must begin withthe basic principle that any tests which are to be con- ducted must be as accurate and precise as possible. This basic principle flows from the fact that regardless of the lackof relevance of the carbon'monoxide co~tent of cigarette smoke in terms of human health, the mere testing and publi- cation of results by the Commission may have commercial impacts which are unwarranted. In addition the Commission should realize that the testing of cigarettes for carbon monoxide content may adversely affect the Commission's already existing program of testing cigarettes for "tar" and nicotine content. The possibility of an adverse impact on the "tar" and nicotine testing program
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- 3 - is particularly acute where the Commission, as now being considered by Mr. Pillsbury, intends to employ a single smoking machine to perform the carbon monoxide tests as well as the "tar" and nicotine tests. There are certain items of equipment currently being considered for a smoking machine to be utilized for carbon monoxide testing as well as "tar" and nicotine testing which would adversely affect the "tar" and nicotine testing. These include the thermistor heat sensor. Use of the thermistor rather than a string cut off process would be likely to adversely affect "tar" and nicotine determinations. Likewise Mr. Pillsburyls • consideration of the use of clearing puffs would be likely to affect "tar" and nicotine determinations. These are only illustrative of the type'of problems encountered if the same equipment is employed to perform the carbon monoxide testing as well as the "tar" and nicotine determinations. These examples underscore our concern that the tests for carbon monoxide content may adversely affect the ongoing "tar"and nicotine testing program. Representatives of each of the six companies visited the Federal Trade Commission testing laboratory and discussed with Mr. Pillsbury the prototype machine which he has been
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- 4 - considering. From these visits the representatives of all six companies emerged with the conclusion that they had made a number of different observations which caused themgreat concern insofar as the abilSty of the Commission laboratory to conduct carbon monoxide tests with sufficient, accuracy and reproducibility. We do not believe that any purpose would be served in cataloging or listing in their entirety all of the aspects of the methodology being considered by the Commission laboratory which caused the industry representatives some concern. Simply by way of illustration these include the dead volume in th~ equipment which can cause both dilution and mixing effects, the lack of proven performance and reliability of the actual CO~analyzer, the possibility of contamination of the carbon monoxide detector cell with extended use and its subsequent cleaning or replacement, the method of lighting cigarettes, and the incapability of the equipment to handle or to analyze partial puffs. More important ~he industry representatives.emerged with the conclusio~that in many different areas the equipment design and methodology were not sufficiently developed and a number of important items had notbeen fully considered and could not therefore be evaluated. For example, the methods O O
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- 5 - of data accumulation and processing are only speculative and vague. No actual e~perience has been obtained on the important problem of possible contamination and cleaning of the carbon monoxide cell. No circuitry diagrams were available, and it was impossible to make any judgment about the electronic circuitry involved in the apparatus. In view of these observations which were made by the industry representatives in the Commissionlaboratory, the industry representatives reached the conclusion that the entire project of possible testing ~f cigarettes for . carbon monoxide content is being considered by the.Com- mission with too much haste and without proper attention to careful and accepted scientific practice. In responding to your letters of July 14, 1976, the six companies had hoped to provide specific comments on the methodology being considered by the Commission for carbon monoxide testing. After the visits of representatives of these six companies to the Commission laboratory the conclusion .~has been reached that it is simply not possible to comment in a meaningful way at this time upon the Commission's proposed methodology-for carbon monoxide testing because that methodology has not been sufficiently developed, it has not been reduced to writing, and data from tests employing that methodology have not been made available for examination.
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- 6 - You have undoubtedly learned from your colleagues on the Commission staff that.when the Commission first proposed a methodology to test cigarettes for "tar" and nicotine content in 1966, the Commission then was proceeding on the basis of an already existing methodology (the Ogg method) which had been published and for which extensive data and collaborative testing had been conducted. As a result of all of these facts and .in an effort to assist the Commission, we respectfully propose that the Commission should not takeany further action with. regard to a determination of whether or not to begin carbon monoxide ~esting until the Commission has completed the following three steps: (I) The Commission.should prepare a' detailed written description of the complete methodology which is to be employed in carbon monoxide testing including a full written description of all of the equipment with circuitry diagrams attached, and this written description should be made available to representatives of the six companies for comment; ~ (2) The ~ommission should conduct tests for carbon monoxide on a large number of monitor cigarettes using its
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- 7 - methodology, and data from these tests as well as the raw data sheets including infrared graphs should be made available to representatives of the six companies for ~ comment; (3) If the Commission has completed satisfactorily items 1 and 2 above, then the Commission should submit its methodology to a number of different laboratories including those of the six companies listed above for a collaborative study of the methodology and also for consideration of the impact of this methodology upon the Commission's "tar" and nicotine determinations. In conclusion it should be noted th&t the repre- sentatives of all six companies who visited the Commission laboratory, have concluded that the Commission laboratory is presently,a long way from having developed a methodology and equipment.which will yield reproducible and accurate results for carbon monoxide testing. -Considerably more work and evaluation must be conducted before the Commission Tan move forward with this testing program. The suggestions offered ~bove are intended to provide a framework for the Commission in which this further evaluation and study can be conducted.
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- 8 - Each of the six companies listed above reserves the right to submit further statements based upon its observations at the Commission laboratory. Very truly yours, Allan J. Topol Counsel for American Brands, Inc., Brown & Williamson Tobacco Company, Liggett & Myers, Inc., Lorillard, Philip Morris Incorporated and R. J. Reynolds Tobacco Company