Chapter 6
Agricultural Chemicals and Cigarette Additives

If one applies a given material to tobacco, three things are important:
1. The characteristics of the material itself.
2. The characteristics of its pyrolysis products [i.e., products produced by burning].
3. The possible alterations in the chemistry of the plant material which may affect the biological activity.
Dr. R. B. Griffith, B&W director of research, April 1967 {1302.01, p. 2}

Introduction

The documents include a number of discussions by B&W officials concerning the chemicals used in the growing and storage of tobacco (agricultural chemicals, such as sucker control agents, pesticides, and fumigants) and in cigarette manufacture (additives). Thirty years ago, B&W officials made genuine attempts to ensure that the agricultural chemicals and additives used in their products were nontoxic, and they expected the suppliers or makers of these materials to take responsibility for ensuring safety. Company officials in this era expressed specific concerns about the possibility that the combustion products of additives might themselves be toxic. More recent documents have a more defensive character, with officials frequently pointing out that a material in question has been declared "Generally Recognized as Safe" (GRAS) for use in food, either by the Food and Drug Administration (FDA) or by the Flavor and Extract Manufacturers' Association (FEMA). Additives on these lists, however, are declared safe in a product that is eaten, not in one that is burned to generate an inhaled smoke. As discussed later in this chapter, Dr. R. B. Griffith, B&W's director of research, recognized in 1967 that a material considered safe when eaten is not necessarily safe in other forms, particularly when it is burned and inhaled in smoke.

Unlike additives to foods, additives to tobacco products are not subject to government regulation in the United States. Since the mid-1980s the cigarette manufacturers have been required to submit a list of tobacco additives used in cigarettes to the Department of Health and Human Services (1), but the department is barred from publishing the list. Moreover, the manufacturers are not required to specify which brands of cigarettes use which particular additives. Quantitative information is similarly lacking. The tobacco companies are not required to disclose anything at all about additives to cigarette papers (such as fillers and adhesives) or to filters (such as plasticizers). In April 1994 public pressure forced the major cigarette makers to publish a version of this list (2), which included 599 materials that might, or might not, be added to any particular brand of cigarettes.

The first page of a file memo dated November 1, 1988 (probably from B&W's law firm in Louisville), provides the following nonexhaustive classification of nontobacco materials that might be found in cigarettes:

flavors
sugars
humectants
casings or sauce materials
insecticides
herbicides
fungicides
rodenticides
pesticides
water conditioners
manufacturing machine lubricants and other chemicals which come in contact with the tobacco and may leave residues on the tobacco {1324.01}

While this classification gives the reader some idea of the range of materials that find their way into cigarettes, the list does not include additives to papers or to filters.

The tobacco industry has used a wide range of additives in cigarettes for decades. Documents dating from as early as April 1965 show that BAT had an "Additives Guidance Panel" to discuss issues related to additive toxicity. In at least one instance B&W continued using an additive even when research suggested that it might pose a health risk to consumers and the panel advised against its use.

Agricultural Chemicals

Sucker Control Agents: MH-30 And Penar

To promote optimal leaf growth, farmers remove the terminal buds from tobacco plants about two months after transplantation from the seed bed into the field (3, 4). This procedure prevents flowering, which results in increased nicotine content in the leaves (4). Removing the terminal bud also controls the total number of leaves the plant will bear. In the absence of the terminal bud, new shoots arise from the axils of the leaves. These "suckers" must be removed by hand, or their growth must be inhibited by chemicals, to avoid sapping nourishment from (and lowering nicotine levels in) the developing leaf. Sucker control agents are chemicals that are sprayed on tobacco plants to slow the growth of suckers and thereby enhance crop yield. These agents—such as MH-30 (maleic hydrazide) and Penar (dimethyldodecylamine acetate)—eliminate the laborious task of removing suckers by hand and therefore lower the labor costs of growing tobacco.

In the mid-1960s the toxicology of sucker control agents was a matter of concern to the Sucker Control Committee, a committee composed of representatives from the tobacco industry and the US Department of Agriculture (USDA). Dr. R. B. Griffith wrote an extensive summary of an April 1967 meeting of this group, in which he had participated {1302.01}. At that time emerging data were suggesting that a commonly used sucker control agent, MH-30, was toxic. Experiments had exposed selected strains of mice to high doses of MH-30, and the significant toxicity that resulted called into question the safety of this agricultural chemical. In his memo Dr. Griffith notes that the USDA has very limited authority to act in such a situation:

Although they [the USDA Pesticide Regulation Division] are greatly concerned, the law requires that others must demonstrate a potential effect on health which is irrefutable. However, they are prepared to act when such knowledge indicates that they should move. {1302.01, p. 1}

The committee members then compared the expected dose of MH-30 to human smokers with the dose administered to the mice; they concluded that the mice had been exposed to two million times the dose that a human smoker consuming two packs of cigarettes daily would ingest.

The committee discussion moved from MH-30 to a consideration of studies on Penar as a possible cause of chromosomal aberrations in plants:

At this point in the discussion, I pointed out that the tobacco problem was unique. If one applies a given material to tobacco, three things are important:

I went on to point out that unusual chemical effects had been noted for each of the new sucker control materials now being considered and that there was no way of predicting the effect that these chemical changes might have on the biological effects of the smoke produced by the treated tobacco. I expressed the opinion that this was a very serious problem and that it was highly desirable for some way to be found to subject treated material to biological tests. In this connection mouse skin painting was not enough since it does not measure whole smoke. Present problems facing the industry certainly indicate the need for assurance that any material used will not result in any detrimental biological effects [emphasis added]. {1302.01, p. 2}

Dr. Griffith's comments reveal a concern with the toxicity of combustion products of additives and of the residues of agricultural chemicals. Although mouse skin painting is an important test for "biological effects" (i.e., carcinogenicity; see chapter 4), it might miss important effects because, as Dr. Griffith pointed out, it relies on painting smoke condensate, rather than whole smoke, onto the experimental animal. In other words, materials in the vapor phase, which are too volatile to be part of the "tar," are not tested in skin-painting experiments. Mouse skin might show no damage from a particular preparation of tobacco smoke condensate, but the smoke might still be highly carcinogenic.

A participant at the meeting indicated that a committee formed by British tobacco companies was "contemplating a series of biological tests" of the new sucker control agents, and that these tests could be replicated in the United States. The memo concludes:

Although everyone there [i.e., in Britain] seemed to recognize the magnitude of the problem, no one seemed to know what, if any, actions could be taken. It was agreed that none of this information would be discussed with the chemical suppliers of any of the sucker control materials, and that no public discussions of this subject could take place until after ... [the] papers [describing the toxicity of MH-30 in mice] have been published [emphasis added]. {1302.01, p. 3}

A year later, Penar was the subject of correspondence between scientists at BAT and B&W. Dr. S. J. Green, a senior R&D scientist at BAT in London, transmitted a Tobacco Research Council (TRC) report on

Penar to Dr. Griffith in mid-April 1968. Griffith, in turn, sent copies to Addison Yeaman, B&W's general counsel, and Dr. R. A. Sanford, a fellow scientist at B&W {1303.01}. The report gave preliminary results suggesting that Penar is toxic. The authors recommended additional testing of Penar-treated tobacco, and they urged B&W to report the alarming initial results to regulatory authorities in the United States and Canada:

The tests on [Penar-]spiked tobacco have now been going for 31 weeks and results reported from Huntingdon [Imperial Tobacco's laboratory in England] at this stage are so disquieting that we consider that they should be reported to the U.S.D.A. and Canadian Department of Agriculture [emphasis added]. {1303.02, p. 1}

We found no indication in the documents whether the data were, in fact, reported to the appropriate government authorities.

Shortly after this report was received in Louisville, on May 1, 1968, Dr. Griffith sent Yeaman a status report along with some background documents on the growing evidence of toxicity from sucker control agents {1317.09}. The report conveys a tone of urgency and helplessness. Griffith recognizes that, although Penar appears to be carcinogenic, he and the cigarette manufacturers have limited power to do anything about it, because Penar is produced by an independent company and is applied to tobacco in the field, months before the tobacco is bought by the cigarette makers.

The tobacco manufacturer is completely at the mercy of the people who use various chemicals on tobacco. Of the chemicals used, MH-30 and Penar have probably been investigated most extensively, and there are certainly indications that these could have detrimental biological effects from smoke. As you know, we have been sitting on the MH-30 "powder keg" for three years and no positive steps have been taken by the government agencies to provide any relief. We now have, as a result of Dr. Green's letter of April 16 [{1303.01; 1303.02}], information which suggests that Penar could be even more of a problem than MH-30. In Dr. Smith's report of April 18, he pointed out that there is a possibility that as much as 25% of the crop in North Carolina will be produced using a combination of MH-30 and Penar. It would seem that something must be done, and since this is an industry problem, we must consider every possible avenue, including bringing this to the attention of the "Less Hazardous Cigarette" Committee [discussed in chapter 4].

If you and your opposite numbers [i.e., attorneys at the other tobacco companies] can agree that this is an industry problem which must be handled on an industry basis, it might be helpful to solicit specific suggestions from the Industry Research Directors [emphasis added]. {1317.09}

Griffith's proposal to deal with the problem directly on an industry-wide basis is in line with the general policy of the R&D establishments

throughout BAT in the 1960s: they were earnestly seeking to lower toxicity in ways that did not fundamentally threaten the product itself (see chapter 4). Thus, the B&W general counsel could be asked to confer with his opposite numbers at competing companies about this "industry problem," because the problem was potentially soluble without threatening B&W's core business. Government could regulate these agricultural chemicals if necessary, and tobacco production would go on.

J. E. Kennedy and R. P. Newton of B&W R&D wrote a "private and confidential" file note in mid-1968 titled "The Relative Carcinogenicity of Sucker Control Agents Maleic Hydrazide (MH) and Dimethyldodecylamine Acetate (Penar)" {1303.03}. It was circulated to Ed Finch, B&W's CEO, Yeaman, and Griffith. The note analyzes two published studies on maleic hydrazide and the unpublished Huntingdon study on Penar. It emphasizes the relatively huge doses of both agents involved in these experiments and describes the combustion behavior of the compounds. According to the report, maleic hydrazide was not changed at high temperature and was therefore not expected to contribute other compounds to cigarette smoke. Penar, on the other hand, decomposed to dimethylamine, dodecaene, and acetic acid. Dimethylamine, in turn, was expected to produce dimethylnitrosamine, which Kennedy and Newton describe as "a strong carcinogen" {1303.03, p. 2}.

In August 1968 Imperial scientists shared their data on the carcinogenicity of Penar with Dr. T. C. Tso, a senior scientist at the US Department of Agriculture, while Dr. Tso was visiting England. This interchange is discussed prominently in a September 13, 1968, file note by Dr. Griffith, which tells of his visits earlier in the month to USDA offices in Beltsville, Maryland. He had meetings there with Dr. Tso and with Dr. Leon Moore, who was in charge of the USDA's tobacco program {1303.04}. After summarizing the data on Penar, Dr. Griffith notes:

Dr. Tso and the people in England consider that these results indicate a very serious potential problem with Penar. This information is being given to the Penar manufacturers and a summary statement has been sent to Dr. T. W. Edminster, Deputy Administrator of ARS [Agricultural Research Service], with a request that he pass this information on through normal channels to the Pesticide Division of the USDA [emphasis added]. {1303.04, pp. 1-2}

Dr. Griffith had thought from a telephone conversation with Dr. Tso on August 28 that Dr. Tso might want additional toxicology work to be done on Penar, but "this impression is erroneous. He intends to accept the English results as definitive for Penar" {1303.04, p. 2}. The additional work was to be done on other sucker control agents.

Dr. Tso is obviously impressed with the procedures being used in England and fully recognizes that valid work should not be repeated. On the other hand, the results obtained on Penar definitely indicate the need for such tests on other compounds used on tobacco. {1303.04, p. 2}

During this same September 1968 visit, Dr. Tso also talked with Dr. Griffith about the work of the Tobacco Working Group and the "Less Hazardous Cigarette Committee" in the United States. The discussion centered on cooperation and collaboration on the production of a standardized cigarette for testing.

The notes of Dr. Griffith's visit to Beltsville also summarize his meeting with Dr. Moore. Dr. Moore and Dr. Griffith agreed "that Penar was a very serious potential problem, but that this was only a specific example of a general problem" {1303.04, p. 3}. At the time, only MH-30 and Penar had been tested, and both had been found toxic. Griffith suggested that a general framework for approaching questions regarding agricultural chemicals should be developed to "prevent the feeling on the part of anyone that the USDA or Industry was attacking any individual company" {1303.04, p. 4}. The exchange indicates that Griffith was interested in developing a systematic approach to dealing with the potential toxicity of agricultural chemicals, and he clearly felt that government regulators had a major role to play. His view on pesticides sharply contrasts with B&W's position on cigarettes—that the government should play no role in regulating toxicity of cigarettes. Griffith endorsed government regulation of potentially toxic agricultural chemicals, but B&W has never wanted the government to regulate its manufactured tobacco products.

Griffith's file note concludes with his encouraging Dr. Moore to share the Penar results from England with other US tobacco product manufacturers. Griffith had known of the results because of the free exchange of research results between BAT and B&W. Other US manufacturers did not enjoy this access to the UK industry's joint research results. Moore indicated that his contact at Imperial Tobacco (John Campbell) had not given him permission to share the data. Griffith encouraged him to try to obtain that permission.

I expressed the opinion that if I were a company who did not have access to the information, I would be very disturbed. The Penar situation could explode at any minute and a company without prior knowledge could be caught in a very embarrassing position. Dr. Moore recognized this and promised to try and obtain permission from Mr. Campbell to pass this information on to the total American Tobacco Industry [emphasis added]. {1303.04, p. 4}

The carcinogenicity of Penar was later confirmed through long-term mouse skin–painting experiments conducted within the BAT system. A report two years later, dated May 18, 1970, from C. I. Ayres, a scientist in R&D at BAT in Southampton, describes the results of a 72-week-long experiment in which tobacco smoke condensates derived from tobaccos treated with two different concentrations of Penar were painted on the skins of mice {1308.01}. The report was sent to the R&D department at B&W as well as to BAT officials in Australia and Montreal. It seems to have originated at BAT's laboratory in Southampton. It refers to the experiment as the "remaining" Penar experiment, suggesting that its long-term results may have complemented short-term assays completed earlier. The experiment would have begun no later than sometime in 1968. In his report Dr. Ayres summarizes the experiments on 1,056 mice:

I am enclosing the latest results (H 685) from the remaining PENAR experiment. The position is unchanged, i.e., there is the indication that the addition ofPENAR to cut tobacco leads to an increase in the tumorigenicity of the condensate [emphasis added]. {1308.01, p. 1}

Thus, by 1970 BAT had demonstrated that an agricultural chemical could detectably increase the already high toxicity of tobacco.

Penar was finally reformulated at some time in the 1970s—years after the initial data which indicated that the original formula was carcinogenic had been developed.

Maleic hydrazide, another sucker control agent, was also reformulated. The diethanolamine salt was replaced with the potassium salt because of concerns that nitrosamines might be produced when tobacco treated with diethanolamine salt was burned (4, 5). Maleic hydrazide has continued in widespread use: in the mid-1970s about 3 million pounds were used on tobacco in the United States (4). The B&W Leaf Division reported that it was having difficulty meeting the standards set by the West German government for permissible levels of maleic hydrazide in tobacco in the 1971 tobacco crop {1317.07}. The report notes, "there is no systemic alternative to maleic hydrazide, but contact suckering formulations based on the long-chain alcohols octanol and decanol are coming into favour, especially in Canada" {1317.07}.

An April 12, 1984, memorandum from K. J. Brotzge, associate research biologist, to E. E. Kohnhorst, vice president for research, development, and engineering (RD&E) at B&W (with copies to Ivor Wallace Hughes, chairman and CEO; Thomas Sandefur, executive vice president; Ernest Pepples, senior vice president and general counsel; and others

{1003.01}), describes the "annual pesticide residue meetings" held at North Carolina State University the previous week {1318.01}. The meeting reviewed an ongoing monitoring program that analyzed levels of residues of agricultural chemicals in various brands of cigarettes. The work was supported by grants from the North Carolina Tobacco Foundation, American Tobacco, B&W, Liggett & Myers, Lorillard, Philip Morris, R. J. Reynolds, and the Tobacco Advisory Committee (UK). The program had supported a graduate student's master's degree work in toxicology. Maleic hydrazide, the sucker control agent, was still evident in cigarettes.

Pesticides

Pesticides have been of concern to tobacco industry scientists because of both the potential toxicity of their residues and the regulatory requirements of some governments. For example, a May 1958 memorandum from the B&W Research Department discusses the possibility of using an outside laboratory to conduct pesticide residue studies for the export department {1317.06}. The analyses may have been required for export of products to West Germany, which regulated levels of some additives and pesticide residues of tobacco products (see below).

A December 1968 letter from the Research Department at Imperial Tobacco in Bristol to the Tobacco Research Council in London documents the results of the department's analyses of DDT residues in samples of the 1967 US tobacco crop {1304.01}.

In our view these figures indicate an unacceptably high contamination [with DDT residues] of the tobacco and we think that they should be brought to the attention of the U.S.D.A. with the request that action is taken to ensure that levels in future crops are lower. {1304.01}

An early meeting of a group called the Agricultural Chemicals Study Group was suggested to review the matter. There seemed to be some urgency to the deliberations:

If there is support for our views it would then be possible for the matter to be raised with the U.S.D.A. in time for them to take some action in regard to the 1969 crop. {1304.01}

The Congressional Record for July 28, 1969, includes an eight-page exploration of the problem of pesticide residues in tobacco by Senator Gaylord Nelson (D-WI) {1307.01, pp. 2–3}. In this entry Nelson declares

his support for a ban on DDT and notes that tobacco has been exempted from regulations limiting the levels of pesticides used on crops.

The first page of a progress report from the B&W Leaf Division's review of the 1971 crop mentions DDT residues in US tobacco {1317.07}. The report indicates that US leaf has levels of DDT residues that "continue to approach the level demanded by the West German legislation, but the levels of maleic hydrazide are still very high."

A June 1983 memorandum from R&D within B&W discusses the advantages of substituting an insecticide named Fican-Plus for Diazinon {1317.01}. The proposed substitute is described as "not as toxic to mammals" and therefore "a desirable replacement"; it also might render the pyrolysis products (the results of burning the chemicals in a cigarette) less toxic. Once again, the company's research scientists are intent on reducing the potential toxicity of a chemical used in tobacco production, as well as the potential toxicity of pyrolysis products of the chemical.

The report of B&W's delegate to the industry-wide "annual pesticide residue meetings" for 1984 (see above) includes a description of a smoke panel test that was to become part of the evaluation of new pesticides for tobacco {1318.01}. This test was to be used to determine whether new pesticides altered the actual smoking experience in any way. The smoke panel is described as follows:

A toxicologist, Dr. Lamar Dale, was hired as an independent consultant. He is to review data packages from pesticide manufacturers when development of a pesticide for tobacco has progressed to the point that smoke flavor evaluations are needed. His evaluation will serve as a basis for judging the safety to tobacco company panelists who smoke experimental cigarettes treated with pesticides. {1318.01, p. 2}

Dr. Dale had been hired to do these evaluations for the entire US cigarette industry. Included in the specific information requested by Dr. Dale was "pyrolytic products at smoldering and ignition temperatures (acutely toxic products, i.e., HCN, CO, etc.)" {1813.02, Appendix III, p. 1}. The report noted that such information "will generally not be available. However, the safety to panelists can be judged through other available information requested" {1813.01, p. 2}. Thus, the committee representing the industry did not question the relevance to consumer safety of their consultant's requested information, but only its availability. The industry as a whole recognized that, in making the safety judgments about pesticide residues in cigarette tobacco, one must consider the toxicity of pyrolysis products (i.e., the results of burning them), not just the unheated form of the residue.

The fact that pyrolysis could increase the toxicity of additives had been recognized by Dr. Griffith in 1967, but the point seems to have been ignored by the industry in recent years. The additive list released by the cigarette companies in April 1994 indicated time and again that one material and another was GRAS or FEMA-approved (2), but nowhere in the listing is any consideration given to whether these additives are safe when inhaled.

Additives

Additives are used to make tobacco products more acceptable to consumers. They might prolong shelf life (humectants), make the smoke milder and easier to inhale (sugars and humectants), add flavor and aroma, improve the delivery of nicotine (ammonia compounds), and numb the throat (menthol and eugenol). For some time public health workers have pressed for disclosure of additives because some of them, or their combustion products, might be toxic (6). On at least one occasion the tobacco industry has considered additives to reduce the carcinogenicity of cigarette smoke. One such proposed additive, called Chemosol, is discussed in the documents.

By 1981 there was a tension between an increased need for additives in product design, because of pressures to lower tar and nicotine deliveries, and the increased likelihood of government regulation. BAT scientists at the Pichlarn, Austria, research conference in August 1981 concluded:

While additives will assume increasing importance in product design, the freedom to use them could become increasingly restricted. {1178.01, p. 14}

The documents disclose several instances in which B&W was reluctant to abandon the use of additives that independent tests on animals had found toxic. Of course, the company was under no regulatory obligation to stop using these additives; however, it appears to have voluntarily discontinued use of some additives by 1994, probably because of the threat of public disclosure and government regulation.

Chemosol: An Additive To Reduce Cancer

In the late 1960s the American cigarette companies briefly joined forces to sponsor the study of a cigarette additive, Chemosol, which promised to greatly reduce the risk of smoking-induced cancer. The willingness of these companies to come together for such an extraordinary activity speaks eloquently to the seriousness with which the whole industry

privately regarded the cancer risks of cigarettes. In addition, the Chemosol story illustrates the extent to which lawyers controlled critical pathways of scientific endeavor about sensitive subjects within the industry.

Chemosol, described in the documents as a "fuel additive," had been developed under the name "flowebin" by a physician named Max Bindig from Munich, Germany {1807.06}. When used as an additive in cigarettes, it was supposed to promote more complete combustion, which would reduce the levels of the carcinogen benzo(a)pyrene (or benzpyrene) in mainstream smoke. When the rights to flowebin were acquired by a US company, the Chemical Research and Development Corporation, the additive was renamed Chemosol and the company was renamed the American Chemosol Corporation.

During 1966 Dr. Perry Hudson, a biologist affiliated with Columbia University, who ran a research laboratory called the High Tor Foundation, conducted a mouse skin—painting experiment in which cigarettes treated with Chemosol were compared with cigarettes that had not been treated {1807.02}. In this experiment mice exposed to standard tobacco smoke condensate developed a high percentage of malignant tumors, whereas animals exposed to Chemosol-treated tobacco smoke condensate did not develop tumors. This result suggested that Chemosol reduced the carcinogenicity of tobacco smoke condensate.

In the spring of 1967, Joachim Schumacher, vice president of McDonnell & Company, agents for the owners of Chemosol, wrote Ed Finch, president of B&W, about the additive {1807.06}. The letter was a follow-up to a meeting between Schumacher and B&W general counsel, Addison Yeaman. While Schumacher was offering B&W an opportunity to obtain an exclusive license for Chemosol, B&W seems to have been committed from the beginning to bringing this potential additive to the attention of the industry as a whole {1807.07}. The file copy of a letter to the executive director of the Council for Tobacco Research, dated December 12, 1967, states:

Some time ago Ed Finch was approached by representatives of Chemical Research and Development Corporation with an offer to negotiate with Brown & Williamson for an exclusive license to an undefined additive to tobacco called CHEMOSOL . It was claimed that CHEMOSOL I ) very significantly reduced the benzo-a-pyrene content of the mainstream smoke, and 2) that smoke condensate from tobacco treated with CHEMOSOL was virtually free of biologic activity. Finch replied that under no circumstance would Brown & Williamson consider such a proposal, but was willing to act as the conduit of information from the promoters of CHEMOSOL to the United States cigarette industry. {1807.07}

Dr. Griffith reviewed the data on Chemosol that Dr. Hudson had prepared and shared his thoughts in a July 19, 1967, memorandum to Addison Yeaman {1807.01}. Although he was impressed with the quality of the technical report and the soundness of the mouse skin—painting protocol that Dr. Hudson had used, he expressed considerable skepticism about Chemosol. He strongly recommended an attempt at replication of Dr. Hudson's study in another laboratory.

Plans for such a replication apparently were already under way when Dr. Griffith wrote this memo. By August 1, 1967, the Hazleton Laboratory in Falls Church, Virginia (a private laboratory), had submitted a draft protocol for testing Chemosol {1807.08}. Finch's initial decision to involve the entire industry in any development of Chemosol was maintained: nine companies (including B&W, Lorillard, R. J. Reynolds, Philip Morris, and American Tobacco) were sponsors of the 1967 protocol that Hazleton had developed (7). However, the experiment had still not been done by the time the matter was brought to the attention of a congressional committee in April 1969.

During the House hearings on cigarette package labeling in 1969, Dr. Hudson testified about his work on Chemosol. He said that it was capable of reducing the benzo(a)pyrene level in cigarette smoke by 34 percent. He described a mouse skin—painting experiment in which only 5 percent of the mice receiving the condensate from Chemosol-treated cigarettes, compared with 25 percent of those whose skin had been painted with the conventional condensate, developed cancer (7). Dr. Hudson also indicated that scientists in academic medicine and from the National Cancer Institute had reviewed the work done on Chemosol and had found it promising. His striking testimony was covered in the New York Times the following day (8), and by the end of August the tobacco industry was publicizing its agreement with Hazleton to proceed with the experiment (9). It appears that the glare of publicity got this project moving again.

On September 10, 1969, representatives of Hazleton met with the research directors of the major tobacco companies to discuss the protocol. Five days later, another meeting was held with representatives of Hazleton, three tobacco company representatives, and two lawyers from Covington and Burling (counsel for the Tobacco Institute) to discuss the fine points of the proposed protocol. The meeting is documented by a detailed set of notes written the following day by Allan J. Topol, one of the two lawyers present {1807.08}. Topol wrote these notes in the form of a memo to the other lawyer who was there, H. Thomas Austern. Austern

was a prominent expert in food and drug law at the time. He had represented the Tobacco Institute before the Federal Trade Commission a few years earlier (10). The lawyers (purportedly on behalf of the research directors) sought to add defensive language to the protocol. According to Topol's memo,

AJT [Topol] stated that the research directors had decided that the objective [statement in the protocol] should include a sentence stating that the relationship of skin painting to smoking and health had not been established. {1807.08, p. 1}

This embellishment was proposed despite the fact that mouse skin painting was being used to guide product development of less toxic cigarettes within the industry (see chapter 4). The Hazleton spokesman, a Mr. Gargus, disagreed with this change on the grounds that such a disclaimer belonged in the final report, not the protocol.

Although Austern was present as counsel for the consortium of tobacco companies sponsoring the research, he made a number of substantive scientific suggestions about the conduct and organization of the project. He asked whether a sufficient number of cigarettes would be available for the entire project, a question that led to agreement to raise the number to be made from 500,000 to 1 million. He offered the services of the Tobacco Institute Testing Laboratory to conduct preliminary quality control testing of the experimental cigarettes, and he suggested that organoleptic tests (human panel tests of subjective smoking qualities) be added to the protocol. He also suggested that the protocol specify the type of cigarette paper to be used in the manufacture of the experimental cigarettes.

Hazleton had planned to assay the smoke of experimental cigarettes for benzo(a)pyrene levels, but Austern objected

in view of the claims made by Chemosol for benzo(a)pyrene reduction, and in view of the decision of the research directors at the meeting of September 10, 1969, that no decision would now be made as to the test for benzo(a)pyrene content, and that such a decision would be made at the termination of the biological tests. {1807.08, p. 3}

The tobacco company sponsors apparently did not want to consider collecting data that might validate Chemosol's claim for reducing benzo(a)pyrene levels unless the additive was first proven to protect mice from developing cancers. The report indicated that Hazleton's proposed assay of the condensate for benzo(a)pyrene would have been for routine quality control. It is interesting, then, to speculate as to why the attor-

ney chose to object to the use of such a routine procedure. Our hypothesis is that if the experiment showed no protection, but benzo(a)pyrene levels were, in fact, lower, this result would suggest that other carcinogens in the smoke were responsible for cigarettes' carcinogenicity.

Austern also objected to the use of benzo(a)pyrene as the carcinogen to be employed for a positive control in the experiment. It was routine practice to include a positive control in these studies, and benzo(a)pyrene was the one that Hazleton had used in the past. (In fact, BAT later used benzo(a)pyrene—which it described as a "pure carcinogen"—as a positive control in precisely this way in its Janus mouse skin—painting experiments {1138.02, p. 4}; see chapter 4.)

Mr. Gargus explained that benzo(a)pyrene had been employed because it was the best known carcinogenic agent and the one generally used in experiments of this type ... HTA [Austern] suggested that Hazleton employ some control other than benzo(a)pyrene in view of the repeated assertions made by Chemosol for benzo(a)pyrene reduction, and in view of the psychological implications of "benzo(a)pyrene" in the cigarette controversy . Mr. Gargus rejected these suggestions, and Mr. Jessup [of Hazleton] stated that unless Mr. Gargus was satisfied on the scientific grounds, Hazleton would not enter into the contract [emphasis added]. {1807.08, p. 4}

Hazleton retained its preferred positive control, but Austern's attempt to get it changed is an example of how an attorney placed public relations concerns—not the lawyer's traditional concern with liability—ahead of scientific judgments.

Topol's account also describes a substantive discussion about the publication of the results of the experiment. Austern sought to establish control of the results by the tobacco companies (see chapter 8):

With regard to publication of the results, Mr. Gargus suggested that Hazleton be authorized to publish the results of its study in a scientific journal even prior to submission of a report by Hazleton to the sponsors, and prior to Hazleton's submission of its final results to the sponsors. In this way, Mr. Gargus stated, Hazleton could secure its scientific reputation by making sure that Hazleton published its test results. Under this approach no-one would see the Hazleton results until they were published. HTA [Austern] disagreed with this suggestion, stating that the sponsors were paying for the work and should certainly see the results before they were published. In addition, publication is generally a matter of the sponsors' discretion. {1807.08, p. 5}

Austern prevailed. After discussion, Gargus agreed to submit a copy of the report to the nine sponsoring tobacco companies for review prior to publication. However, he insisted that there be an explicit clause in the

contract relating to publication rights. This matter was to be decided later, after Austern had had an opportunity to discuss it fully with his clients.

The following suggestion was also made at this meeting:

HTA [Austern] further suggested that AJT [Topol] should be present at any future technical discussions between Hazleton and industry representatives. {1807.08, p. 6}

In other words, a Convington and Burling lawyer was to participate in all scientific discussions about this experiment between Hazleton and the sponsors.

An interesting facet of the Chemosol story is Ed Finch's insistence that the additive be tested and developed as an industry-wide joint project. Finch may have felt this way for two reasons. In the United Kingdom BAT was part of an industry-wide consortium, the Tobacco Manufacturers' Standing Committee (TMSC), which was committed to the joint development of safe cigarette technology through its Harrogate research lab. Moreover, B&W may still have harbored memories of the reaction felt within the company when Lorillard had gone out on its own in 1962 and developed a filter that selectively removed phenols (see chapter 4). Eight other cigarette manufacturers agreed with B&W's position that Chemosol should be examined jointly, despite the fact that the joint development of a commercially important additive might have invited examination of this activity from an antitrust perspective (see chapter 7).

The documents provide no information on whether the Hazleton protocol was ever implemented or, if it was, what the results may have been. We are not aware that there was any further press coverage, either. There is no indication that Chemosol was ever used commercially.

What is certain is that nine cigarette manufacturers were willing to sponsor research on an additive that promised to reduce the risk of cancer from cigarette smoking; and this venture was coordinated by a lawyer who had worked for the Tobacco Institute. The record of the 1969 negotiation session about the protocol indicates that lawyers played a remarkably large role in discussions about the procedures for carrying out the scientific work. Moreover, there were plans for continued involvement by lawyers in the Chemosol studies at every significant step.

Freon

Tobacco used in cigarettes may be "puffed" or expanded by a variety of processes. Expansion decreases the mass per unit weight, which is one way to reduce "tar" delivery and total tobacco content of a cigarette. In

the 1970s R. J. Reynolds developed a process called G-13, which used Freon-11 for expanding tobacco (11, 12). The process was used by RJR, Liggett & Myers, American Tobacco, and Lorillard. Only Philip Morris and B&W were not using this process as of mid-1977 {1309.01}. An undated and unsigned report, apparently reviewing toxicology studies conducted by RJR for B&W, indicates that in the 1970s RJR tested Freon-11 for its carcinogenicity in mouse skin–painting experiments and also attempted to determine whether Freon had any acute toxicity for the respiratory system {1309.04}. The report indicated that scientists at RJR found no evidence that Freon-11 was toxic under the conditions tested, but the report expressed reservations about these conclusions, since the data had not been evaluated by an independent, outside consultant.

A June 2, 1977, memorandum from Ernest Pepples, the general counsel at B&W, to Dr. I. W. Hughes, head of R&D, describes Pepples's objections to B&W's use of tobacco treated with the G-13 process {1309.01}. Environmental groups had filed petitions with the Consumer Product Safety Commission, and the Environmental Protection Agency was raising concerns that Freon could decompose into the poisonous gas phosgene (which had been used in World War I) when it was burned. The petitioners asked that Freon be banned from air conditioning systems because of this potential hazard. Pepples believed that the finding of phosgene in cigarette smoke might present an opportunity for a products liability claim {1309.01, p. 3}. Moreover, some scientists suspected that Freon could damage the ozone layer of the atmosphere. Pepples worried that the same thing was happening when the Freon residue on the tobacco was heated by the burning coal of a cigarette {1309.06}, although it was not then publicly known that Freon was widely used within the cigarette industry {1309.01, p. 2}:

As we have previously discussed there are three problem areas in the use of the G-13 process:

Pepples also made a strong argument for environmental protection:

There is another factor about which extensive comments are not needed. I refer to the morality of a step which would add 600 lbs. of F-11 [Freon-11] per day to the environment in the face of the already substantial scientific evidence that the chemical is actually harmful to the environment. {1309.01, p. 2}

Pepples recommended that other processes be developed.

A memorandum dated December 5, 1977, from Stanley L. Temoko of Covington and Burling to the Committee of Counsel, a Tobacco Institute committee consisting of the chief counsels of the member companies, shared the news that the Consumer Product Safety Commission had denied the citizen petition "requesting a ban of 'Refrigerant 11' under the Consumer Product Safety Act" {1309.05}. With the threat of regulatory action against Freon diminished, Brown and Williamson began to utilize the G-13 process {1309.02}.

A May 1, 1978, memorandum from J. W. Webb, a research scientist at B&W, discusses the analysis of an expected shipment of expanded tobacco {1309.03}. Tests to be run included moisture content, glycerin content, residual Freon level, yield, percent fines, and fill value. These measures indicate that B&W was evaluating expanded tobacco made elsewhere for possible use. In June 1978 B&W signed a contract with Liggett Group to buy Liggett's excess capacity of G-13 processed tobacco {1309.02}.

Cigarettes With "Nothing Artificial Added"

Cigarettes are more than shredded tobacco wrapped in paper. Additives are required for the tobacco, the papers, and the filter for a variety of purposes. The core need for some additives in modern cigarettes is revealed in a July 1977 memorandum summarizing a meeting at which B&W executives critically examined the claim "nothing artificial added" that RJR was then making about its new brand, Real {1311.01}. Real brand cigarettes had been launched by RJR in 1975, and a menthol version was marketed in 1977. Real contained glycerin (which could have been derived from natural sources) as a humectant; it also contained sugars (and possibly flavorings) for casing the tobacco used in the blend. The menthol version of Real might have contained natural menthol, but that was not yet clear to the B&W group.

B&W could match the RJR claim with a new brand if need be, and it could even use a claim of "all natural flavors." However, the use of "such artificial elements as cellulose acetate, plasticizers, freon, propylene glycol, humectants and some flavors" would preclude the assertion of a "pure organic" claim {1311.01, p. 1}. Propylene glycol, a manufactured chemical commonly used as a humectant by both B&W and RJR, could not be used in a cigarette claiming "nothing artificial added." Tobacco extracts were felt to be "nature identical" at best. Their use in a cigarette would preclude a claim of that brand's being "natural" {1311.01, p. 2}.

The observation that tobacco extracts are not "natural" runs counter to the impression sometimes given by tobacco companies that tobacco extracts are, simply, a form of tobacco. In 1988, when RJR explained its novel nicotine delivery device, Premier, to the scientific community, it described the tobacco extract used in the product as "spray dried tobacco" (13). This phrase was used to suggest that the extract was tobacco, just as certainly as tobacco leaf was. The contrary view expressed privately a decade earlier by B&W scientists in Louisville contradicts this contention.

Eugenol

Eugenol, the active ingredient in cloves, is a local anesthetic agent. It is important for clove cigarettes (cigarettes made from a mixture of cloves and tobacco), which constitute an enormous share of the cigarette market in Indonesia, where BAT has long produced conventional, Western-style cigarettes in competition with clove brands. Traditional clove cigarettes have high tar and high nicotine yields and are made from dark tobaccos instead of the light or blond tobaccos used in Western-style brands. The dark tobaccos produce a harsher smoke, and it is thought that the cloves make it easier for a consumer to inhale the smoke because of the anesthetizing action of the eugenol (14).

B&W was using eugenol as an additive in its cigarettes in 1979 {1822.04}. Eugenol was approved as an additive in cigarettes by BAT's Additives Guidance Panel because of its successful performance in inhalation tests, Ames tests, and other tests from 1982 {1006.01}. The Additives Guidance Panel was an internal BAT group that met in London to review recommendations by its Research and Development Establishment on tobacco additives from various suppliers. Although the government in Jakarta forbade foreign companies from making clove cigarettes, Indonesian clove cigarette manufacturers had begun establishing markets for these products in Australia, Malaysia, and the United States by the early 1980s. This situation afforded BAT a potential market opportunity outside Indonesia for selling clove cigarettes. A summary of the toxicology of eugenol is contained in a 1982 report {1133.01}. This document may be the sort of report on which the Additives Guidance Panel based its decisions.

BAT's interest in eugenol was broader than the Indonesian market, however, and its conception of the pharmacological role of the compound was larger than the local anesthetic action. The BAT research conference held in Brazil in 1983 included a session devoted to eugenol

{1180.28, pp. BW-W2-03741–BW-W2-03742; 1180.07, p. 12}. The discussion centered on developing techniques for measuring eugenol so that its pharmacokinetics and pharmacology could be worked out. Of particular interest to the BAT scientists was its possible action as a central nervous system (CNS) depressant, one that was possibly synergistic with barbiturates and alcohol {1180.28}. The conference summary on eugenol states:

Recognizing the potential for eugenol-flavoured cigarettes in countries outside Indonesia (eg Australia, Malaysia, USA), support was given for the proposed limited GR&DC [Group Research and Development Centre] programme to assess the pharmacology, biochemistry and toxicology of eugenol and its smoke products. The study will include the possible interaction of nicotine as a stimulant with eugenol as a depressant . Significant progress can be expected on this project within one year [emphasis added]. {1180.07, p. 12}

Cocoa

Cocoa has long been an ingredient in American blend cigarettes. In the 1970s the National Cancer Institute's (NCI) cigarette testing program found that cocoa added to a tobacco blend increases the carcinogenicity of cigarette smoke condensate {1319.03}. While the results were not statistically significant, they prompted the British government to ban the use of cocoa in tobacco products. By 1983, however—after additional toxicological data were submitted to the British government's Independent Scientific Committee—the cocoa ban was lifted in the UK for additions of cocoa up to 5 percent of the tobacco weight {1319.03}

An article about cocoa came to the attention of senior executives at B&W in June 1984. The article itself is not in the documents, and it is not clear how it came to B&W's attention. General Counsel Ernest Pepples shared the article with B&W executive vice president Thomas Sandefur, who in turn passed it on to E. E. Kohnhorst, vice president of R&D {1319.02}. Kohnhorst asked Gil Esterle, B&W manager of smoking and health affairs, and Jim Rosene, a B&W research scientist, to analyze it {1319.01}. Esterle and Rosene gave their report to Kohnhorst by early July {1319.03}.

Esterle and Rosene's report confirms that cocoa is used extensively by the industry as an additive and summarizes the NCI findings that cocoa increases the carcinogenicity of tobacco smoke condensate. In B&W products, the report indicates, cocoa levels in cigarettes are about 0.5 percent and up to 5 percent in pipe tobaccos; Philip Morris and R. J. Reynolds

use about the same amounts of cocoa, but Lorillard has replaced cocoa with a proprietary substitute. Lorillard's substitution of something else for cocoa had been verified by the absence of theobromine (an alkaloid in cocoa) from Lorillard brand cigarettes. The document continues:

In the recent past, we attempted with only very limited success to delete cocoa from our cigarettes. Cocoa is incorporated in most of our new products. To eliminate cocoa from all our brands would be a multi-year, costly program, with all indications of minimal success as measured against competitors [sic ] products that use cocoa. Consequently, we recommend not actively pursuing a cocoa deletion/replacement program at this time. Rather the industry should defend the use of cocoa [emphasis added]. {1319.03, pp. 2–3}

A handwritten summary of this report indicates that Kohnhorst shared the main points with Sandefur {1319.01}. So, even though Lorillard had successfully stopped using cocoa in its cigarettes, B&W decided not to do so itself because of economic concerns. The data indicating that cocoa increases the carcinogenicity of cigarette smoke did not seem overwhelming to B&W at the time, and there was no governmental pressure for it to make the change.

Coumarin (Deer Tongue)

Coumarin, which imparts a vanilla-like flavor and is a flavor fixative, was used as a food and tobacco additive for many decades. It was especially valued by tobacco product designers as a flavor booster in low-tar brands. Most commercial use was abandoned when it was discovered that coumarin caused liver damage in both rats and dogs and was suspected of being carcinogenic.

Some background on the B&W attitude toward coumarin is reflected in the January 1978 minutes of an internal BAT Additives Guidance Panel meeting on November 15, 1977 {1310.02}. The minutes indicate that numerous additives were approved for use, and that coumarin received special consideration:

The Hunter Committee [an independent committee in the UK which advised the government on smoking and health] have now considered the Final Report from BIBRA [British Industry Biological Research Association, a report apparently sponsored by BAT (see below)] but were unable to approve levels as high as those recommended by the panel at their last meeting. The reason for this was that the Hunter Committee took into account not only the intake of coumarin from tobacco smoking but also that likely to be ingested from foods in normal diets having a content of natural coumarin. Accordingly,

for the United Kingdom: THE PANEL RECOMMENDS THAT WHERE COUMARIN IS USED AS A TOBACCO ADDITIVE THE RATES OF APPLICATION SHOULD NOT EXCEED

While the limits by the Hunter Committee must be observed in the U.K. the Panel saw no reason to modify their general recommendation of revised limits (740ppm for cigarette tobacco and 1500ppm for pipe tobacco) for other countries, where no legal restriction is imposed. {1310.02, pp. 1–2}

In other words, BAT would observe the UK's prescribed limit on coumarin for products sold in the United Kingdom but not for products sold elsewhere.

On June 6, 1984, E. E. Kohnhorst, sent Thomas Sandefur a memo on coumarin in response to an inquiry from Sandefur {1320.02}. In this memo Kohnhorst indicates that R. J. Reynolds's Now and Vantage cigarettes had coumarin in them in 1982 and 1983, respectively, but the 1984 products no longer did, and efforts were under way to remove coumarin from the "RALEIGH/FIESTA flavor package."

Coumarin is specifically rejected by FDA for use on foods. This rejection was based on very questionable animal studies; but, the FDA has not lifted the ban.

BAT sponsored a study by B ritish I ndustry B iological R esearch A ssociation [BIBRA] on coumarin. The BIBRA study, which is published, showed that coumarin is of no health risk in long-term feeding to baboons.

Presented with the BIBRA results, the UK Independent Committee on Smoking and Health (Hunter, Frogget) lifted this past refusal to allow use of coumarin on tobacco products. This was published in the London Gazette. So, coumarin can be used in the UK and other areas under English influence. BAT (Germany) presented the BIBRA finding to their government decision-makers and were subsequently granted limited approval to use coumarin. This was with low delivery cigarettes (need flavor to induce good smoking quality). There was the requirement to repeat the early studies on coumarin to show they were in error. This accounts for cautious, limited use.

The BAT Additives Guidance Panel (AGP), since the BIBRA findings, has opened [opined?] that coumarin can be used.

BARCLAY originally had coumarin (12 ppm), but it was removed from the flavor formula in November, 1982 . Export cigarettes produced by B&W have not contained coumarin since June, 1983 . We do not sell licensees/associates coumarin or coumarin-containing botanicals [emphasis in original]. {1320.02, pp. 1–2}

Two weeks later, C. J. Rosene wrote General Counsel Ernest Pepples (with a copy to Kohnhorst) about coumarin substitutes {1320.01}:

There are no compounds or formulated flavors available to us that can accurately replace coumarin as a flavor on tobacco. Coumarin itself and natural substances containing coumarin are prohibited from direct addition to food as cited under 21 CFR [Code of Federal Regulations ] 189.130.

Two homologs, 6-methylcoumarin and dihydrocoumarin, exhibit coumarin-like qualities on tobacco but neither can be used as a direct replacement. Both compounds are FEMA-GRAS but are not listed as approved direct food additives by FDA.

We currently use an IFF [International Flavorings and Fragrances, Inc.]-formulated coumarin substitute on BARCLAY . It does not match coumarin very well either.

Attached is a list of domestic brands containing vanillin, mace oil, and glycerin, added either as pure compounds or as part of proprietary flavors. {1320.01}

While FEMA regarded the listed coumarin substitutes as "Generally Recognized as Safe," the FDA did not.

The following month, on July 19, Dr. Sam R. Evelyn from BAT's research laboratory in Southampton sent Kohnhorst a packet of material from his files on coumarin. The material includes reports and site visits to labs conducting animal studies on coumarin as well as a letter from a pathologist at the FDA who had re-reviewed slides from a supposedly positive animal study of carcinogenesis; he had not confirmed the initial report of cancer but had confirmed that coumarin caused liver damage. While the background material Evelyn provided his colleague at B&W is generally negative or noncommittal, his letter indicates that current work with coumarin-feeding experiments was showing some instances of metastatic cancer in the animals. He speculated that such results would likely lead some countries to ban coumarin from tobacco products {1323.02}. Even though the United States had not eliminated coumarin from tobacco as of 1994, it did not appear on a list of cigarette additives released by the six major cigarette manufacturers (2).

Diethylene Glycol (DEG)

Humectants, or moisturizing agents, are used in cigarette tobacco blends to assist with aerosol formation and thus make cigarette smoke "milder." The more that nicotine can be dissolved in the tar droplets, the less irritating the smoke is to the consumer's throat and the easier it is to inhale. Diethylene glycol, more familiar to most readers as an automotive antifreeze, was introduced as a humectant in cigarettes in the 1930s by Philip Morris.

Humectants were reviewed by BAT's internal Additives Guidance Panel in April 1965 {1310.01}. The minutes of the April 9 meeting make the following observations about humectants:

Di-ethylene glycol After some discussion, the Panel members present agreed that because a) there is a known cumulative effect of small doses of this material in the kidneys, and b) there are some other doubtful aspects, it would advise against its use.

Glycerol as a tobacco additive The Panel took the view that, although there was no known reason at present to suppose that this material should not be used on tobacco products, it should, in view of the observations (not supported by references) made on page 62 of the U.S. Surgeon General's Report "Smoking and Health" [the 1964 report] and because of its wide use in the Group, be investigated by R.&D.E. [Research and Development Establishment] both biologically and chemically.

Propylene glycol as a tobacco additive The Panel agreed that this material should also be investigated by R.&D.E. both biologically and chemically. {1310.01, pp. 1–2}

The 1964 Surgeon General's report stated (15, p. 62):

Cigarette manufacture in the United States includes use of additives such as sugars, humectants, synthetic flavors, licorice, menthol, vanillin, and rum. Glycerol and methylglycerol are looked on with disfavor as humectants because on pyrolysis [burning] they yield the irritants acrolein and methylglyoxal. Additives have not been used in the manufacture of domestic British cigarettes since the Customs and Excise Act of 1952, Clause 176, and probably longer, inasmuch as Section 5 of the Tobacco Act of 1842 imposed a widespread prohibition on the use of additives in tobacco manufacture.

Despite the recommendation from the Additives Guidance Panel, B&W was still using DEG twenty years later. In June 1984 R. H. Sachs, deputy general counsel for B&W, wrote to Ernest Pepples, J. G. Esterle, and C. J. Rosene about recent discussions between B&W and Union Carbide, the company that was selling diethylene glycol to B&W {1322.02}. In the course of the discussions, a Union Carbide sales representative said that the company had not known that B&W was using DEG in smoking products and that it would not sell DEG to B&W for this purpose. According to Sachs,

Scientific references were cited to us as the bases for their action. Our scientists read the references, but could not see what Union Carbide was so upset about.

We received a letter from the Union Carbide sales representative stating that DEG could not continue to be used on smoking tobacco because of health concerns, that Union Carbide would be glad to supply a substitute, and that Union Carbide only recently found out about our use of DEG on smoking tobacco.

I contacted the Union Carbide General Counsel to discuss the matter. After an investigation, a lawyer in his office called me to say:

They are willing to cooperate in any way they can to rectify this situation.

While Union Carbide is satisfied that our continued use of DEG in smoking tobacco does not pose a health hazard, we should not let the matter rest there. If the "ingestion" of DEG applied to chewing tobacco is a problem (as Union Carbide seems to indicate it is), then how is it that they are so sure that its inclusion in smoking tobacco poses no problem?

We will look into this matter further [emphasis in original]. {1322.02, pp. 1–2}

The memo includes handwritten notations indicating that Earl (Kohnhorst) asked Gil Esterle whether the effort to eliminate DEG was continuing. Esterle replied that it was. He noted that DEG was not "Generally Recognized as Safe" by either the FDA or FEMA, and that it was not used in foods.

[I]f we need to someday release to government we will need to vigorously defend and public reaction would be negative (I don't trust confidential disclosures to government). We should replace but with a good match. {1322.02, p. 1}

The list of additives released by the tobacco industry in April 1994 does not include DEG (2).

Public relations seems to have become the guiding force for managing potentially toxic additives such as DEG, as it finally became for dictating how to handle matters related to the toxicity of tobacco (see chapter 4). The operative approach was that ingredients for cigarettes must be proven dangerous, and an acceptable substitute be available, before changes would be made. The usual expectation for consumer products, however, is that safety should be established before a product is used.

Disclosure Of Additives

Since 1981 or even earlier, public health workers had been calling for legislation requiring that manufacturers specify the additives used in tobacco products. In 1984 they received a phantom of what they had

sought. Section 7 of the Comprehensive Smoking Education Act (Pub. L. 98-474), passed in 1984, included the requirement they had been seeking—namely, that manufacturers must disclose the additives to the Department of Health and Human Services—but added conditions that rendered the "disclosure" virtually worthless: the additives were to be shared only as an aggregate list, quantitative information was not required, and the information was to be treated as a "trade secret" and not disclosed to any unauthorized person. The veil of secrecy that this useless provision imposed was partially torn down in April 1994, when the cigarette manufacturers, under public pressure, voluntarily released an additives list. The B&W documents provide some background on the industry's attitude toward additives and their disclosure.

Lawyer Concerns Over Additives

From a legal standpoint, the tobacco industry has had good reason to be concerned about the potential hazards of additives. While it is one thing, in terms of products liability, to provide an essentially "natural" product to a consumer, it is quite another thing to alter that product by adding dangerous chemicals to it. For example, one might compare the difference between cigarettes without additives and those with additives to the difference between an apple that naturally contains arsenic in the core and an apple that has also been sprayed with DDT. The industry has generally defended products liability suits on an "assumption of risk" theory; that is, the smoker knew that cigarettes might be dangerous and assumed that risk in deciding to smoke. With the advent of the cigarette warning labels in 1965, this defense became even more formidable, because juries (who were unaware of the addictive nature of cigarettes) refused to believe that smokers did not know the risks they were encountering. However, those juries might have taken a different view if they had been told that the cigarettes smoked by the plaintiff were not merely made of cut, blended tobacco, but, in fact, contained numerous harmful additives that presented health dangers in and of themselves. There is also, when one considers potential health risks, a difference between an additive in its original state and an additive when burned in a cigarette. An additive that might be totally benign from a human health standpoint when in its original state might, nevertheless, be a serious health hazard when burned in a cigarette in combination with hundreds of other chemicals. Thus, even if the manufacturer of an additive had conducted sufficient testing to ensure its safety, a tobacco company us-

ing the additive in its cigarettes was still faced with the problem of determining the safety of the additive when burned in a cigarette.

Attorneys at B&W actively worked to keep abreast of the latest research dealing with cigarette additives. On December 26, 1978, Ernest Pepples sent a memo {1822.01} to Dr. J. G. Esterle, referring to an attached report (not in the documents) by the National Cancer Institute (NCI) on its bioassay of dl-Menthol for possible carcinogenicity and an attached list (also not in the documents) of chemicals being tested for carcinogenicity in the NCI program. Pepples asked, "When you have had a chance to look over the list please give me a call." Whether or not Esterle phoned Pepples, he did send him a reply memo on January 8, 1979, enclosing "a listing of chemicals which are included in the list of chemicals being tested for carcinogenicity in the NCI program and which are known or we consider likely to be present in cigarette additives" {1822.03}. Two days later, Pepples sent a letter to Fred Panzer at the Tobacco Institute asking him to "track" progress NCI had made in testing the very list of chemicals that Esterle had sent along to him {1822.02}. The list consisted of:

Chemicals Which Are Currently Used
     Benzyl acetate
     Cinnamaldehyde
     Eugenol
     D Limonene
     Safrole (mace)
     Titanium dioxide (filter tow, paper)

Chemicals Which May Be Present in Current Additives
     Allyl isovalerate
     Benzyl alcohol
     2,6 di t Butyl p cresol
     Cinnamyl Anthranilate
     Furfuryl alcohol
     Geranyl acetate
     Gums
     Isophorone
     a Methyl benzyl alcohol
     Propyl gallate
     Pyridine {1822.04}

Among the chemicals listed as being currently used, only cinnamaldehyde was named by the cigarette industry as an additive to

tobacco in 1994 (2). Titanium dioxide is still used as a whitening agent for cellulose acetate filter tow, but it is not added to tobacco.

B&W's Policy On Testing Additives

In 1967 Dr. R. B. Griffith, director of research at B&W, informed a group of USDA scientists and other officials that they must test combustion products of residues in tobacco to be assured of their safety {1302.01, p. 2}. By the 1980s this sensibility is no longer evident in the documents. Rather, concern about the toxicology of combustion products is termed "unscientific" and is projected onto critics and potential regulators.

Dr. J. G. Esterle, manager of smoking and health affairs at B&W, wrote a memo to Dr. R. A. Sanford, vice president for R&D, on September 11, 1981, about a "suggested program for testing biological activity of our cigarette additives" {1314.01}. The proposed program first takes note of B&W's additive policy and a criticism this policy has received.

B&W's policy on cigarette casing and flavoring ingredients is:

"To be used as a casing or flavoring in any of our cigarette products, an ingredient added to tobacco shall meet one of the following criteria:

Adherence to this policy provides B&W with a very favorable position in defense of our usage of flavors and casings. Yet, the regulatory and antismoking agencies have identified, at least from a PR standpoint, a weakness. This is that the additives are potentially altered during smoking which may provide a new health risk to the smoker. However unscientific this attack may be, we should be prepared to respond. The program, described here, is designed to provide that response [emphasis added]. {1314.02, p. 1}

These criteria permitted B&W to use any current additive, since only one of the criteria need be met and the first one essentially grandfathered all existing additives regardless of possible dangers. Moreover, the concerns expressed in the 1960s by a company scientist about the need to examine the combustion products of pesticides for toxicity are now instead attributed to outside, anti-tobacco critics.

The proposed solution was to conduct Ames testing of cigarette smoke from cigarettes, with the test additives added at ten to twenty times the

normal level {1314.02}. The Ames test is a test of mutagenicity which has been used as a screening test to predict carcinogenicity. Other screening tests were considered but discarded as inappropriate. The concern seems to have been focused exclusively on the possible carcinogenicity of pyrolysis products of additives. Esterle suggests that each flavor formula for each brand be systematically tested. The initial wave of testing was to be completed by July 1982. The tone of this proposal is purely defensive. The impression one gets is that the purpose of the test is not to determine whether there might be real problems but simply to obtain data that might be used if the company were forced to describe the toxicology of its additives in connection with a lawsuit or if the federal government were able to require the disclosure of additives.

Internal Debate Over Disclosure Of Additives

Two weeks after Esterle had formulated the defensive strategy for testing additives, J. K. Wells III, B&W's corporate counsel, wrote Pepples a "thinkpiece on the additives issue" {1316.01}. In his memo Wells summarizes discussions at a Committee of Counsel meeting held two days earlier. Representatives of B&W and five other companies attended the meeting and presented their views about disclosure of additives in the face of increasing pressure from the Department of Health and Human Services (HHS) and Congress. Wells describes the positions of the other five companies as follows:

RJR : Continue meetings with HHS at the industry's initiation and two or three meetings from now submit to HHS a list of commonly used casings and flavorings which would include about thirty items.

PM : Submit a list of about fifty items soon.

AMERICAN : Submit a list of the most heavily used casings and flavorings at any time.

LORILLARD : Stall any disclosure by industry as long as possible; industry should immediately appoint an independent panel of reputable toxicologists to review a list of as yet undetermined items.

L&M : Stall disclosure and industry should immediately appoint one independent toxicologist to review a list. {1316.01, p. 1}

Horace Kornegay of the Tobacco Institute indicated that the pressure from Congress was based on the industry's failure to disclose. Stanley Tempko, a lawyer at Covington and Burling, indicated that an industry-sponsored review panel would lack credibility.

The memo lists a series of pros and cons regarding disclosure. In favor of disclosure was the argument that there are no known toxicological problems, only "uncertainty," and that disclosure would solve the problem and reduce congressional criticism. Against disclosure was the argument that this is part of a long-term attack, that "anti-industry activists" would use such a list to their advantage, and that adverse scientific opinion would form around the list.

The pros and cons of an independent panel are also enumerated in the memo. The approach avoids legislation and mandatory disclosure while improving the public image of the companies. On the other hand, "products liability litigation risk is increased because of the possibility that the industry appointed panel might conclude that certain additives have problems," and the panel is "unnecessary because the problem will go away if the industry simply discloses some number of its additives" {1316.01, p. 3}.

Bob Northrip, an attorney from Shook, Hardy, and Bacon, proposed that each company do a critical review of its own additives and discard those with problems:

If company testing began to show adverse results pertaining to a particular additive, the company control would enable the company to terminate the research, remove the additive, and destroy the data. Hopefully, the company testing would be done prior to adoption of an additive, but if tests were made of an additive in current use the additive would be discontinued and eliminated from the C&B [Covington and Burling] list before HHS had the opportunity to make adverse comment [emphasis added]. {1316.01, p. 3}

Such a company-by-company sanitized list could then be channeled through Covington and Burling, the Tobacco Institute's counsel, to HHS.

Wells then puts forth the B&W position:

Key factors in assessing the industry position on additives will probably be:

We cannot argue that there is no increased products liability risk inherent in the B&W position. However, the increased risk must be judged against alternatives forecast for the future. If, following disclosure, adverse scientific comment about currently used additives and the claimed failure of the industry to perform adequate testing prior to usage become major public affairs issues, the result would also be an increase in products liability risk. Is

it feasible to expect each of the companies to do review and testing of its additives and remove problematical additives from usage and from the list? If so, then the risk of adverse finding by industry toxicologists is substantially reduced. If not, then the Northrip scheme to prevent adversity subsequent to disclosure is not available.

There appears to be some confusion that the recommendation of an independent industry panel of toxicologists is primarily for the purpose of developing information about our additives. Of course, this is not the case. The industry panel is a formal mechanism for self-policing as part of an industry strategy to gain HHS sanction. The panel is not intended as a substitute for each company's own review and testing of its additives.

The best pitch for B&W's position on additives might be as follows:

The industry can improve public acceptance of its products through HHS approval of industry self-policing of additives. Self-policing will involve research at some point in the future when the research can be satisfactorily set up; immediately the formal mechanism for self-policing would involve only literature review and opinion. It is assumed that the companies will have done their own private review and research of additives and eliminated any which cannot be defended. {1316.01, p. 4}

One of the interesting aspects of the Wells memo is the weight assigned by Wells to public relations and marketing ("public acceptance of [industry] products"). Indeed, the tenor of the memo is that such considerations were deemed of greater importance than the products liability and regulatory concerns that were the lawyer's professional responsibility. Also striking is the suggestion that a panel might serve as a mechanism for self-policing, without having as a primary purpose the development of information about additives, and would instead limit itself to literature review. The industry panel seems proposed primarily as a means of maintaining the privacy—secrecy—of the past use of additives that "cannot be defended." The lawyers seemed to assume that such additives existed. (Indeed, the memo states that Bob Northrip assumed that four or five additives would have problems, not as his own assumption but "because it had been stated as a probability at the table" {1316.01, p. 3}.) If such additives were eliminated from any list given to HHS, then their past use—and the research on health effects—need not be disclosed. Indeed, the suggestion was that past use of toxic additives be affirmatively concealed by destroying adverse data.

The speculation in 1981 that disclosure would blunt criticism was validated in 1994. Following a crescendo of criticism in Congress and in the press about the "secret" additive list, the cigarette manufacturers released a general, overall list in the spring (2). A few days' worth of press stories followed, but little else came of the disclosure.

In the midst of congressional consideration of the bill that required disclosure of additives to HHS, B&W hired outside consultants to test its additives. The Additives Guidance Panel within BAT was to be excluded completely from the project. It is not at all clear that they would even be informed of the project. A note in the documents summarizes a conversation among E. E. Kornhorst; Dr. I. W. Hughes, a B&W scientist; Ernest Pepples, general counsel; and T. Sandefur, who would soon become president. The note, written by Kornhorst on June 8, 1984, reads as follows:

We are going outside to obtain the best expert in toxicology/biological testing. The purpose of this effort will be:

Ernie Pepples and myself will be the only B&W contacts. Once an initial protocol is developed by outside consultants, we will review the same with BAT, given their high involvement with biological and [toxicological] testing. In addition to standard toxicology, the reaction product of combustion might also be considered.

The current Additives Guidance Panel will not be involved in any way in this activity. {1321.01}

The documents contain no information about this program of toxicological testing, nor does the note indicate what exactly prompted this course of action, although the pending congressional action, as well as the revival of products liability suits at about the same time (e.g., the Cipollone case, discussed in chapter 7), may be more than coincidental.

Conclusion

A large number of chemicals are used in the growing, processing, and manufacture of tobacco. Residues of agricultural chemicals and chemicals added during manufacture contribute to the final product. Additives enhance the finished product in numerous ways.

From the late 1960s through the early 1980s, BAT's Additives Guidance Panel systematically reviewed additives. In the 1960s a B&W scientist expressed concern about the toxicology of combustion products of residues in tobacco. By the 1980s this perspective was characterized internally by some at B&W as "unscientific" and was regarded as a tactic by industry opponents in public health. Throughout the period, from the

1960s through the 1980s, legal, public relations, and regulatory concerns about agricultural chemicals and additives are evident in the documents.

The cooperative industry work on Chemosol demonstrates that the US cigarette companies could come together to investigate an additive that promised to reduce the cancer risk posed by smoking. It also demonstrates the central role industry lawyers had in guiding scientific research. The discussions about eugenol at the Brazil research conference in 1983 reinforce the evidence that BAT was interested in the pharmacological effects of smoking on its consumers.

The overall approach to agricultural chemicals and to additives reflected in the documents parallels that taken with nicotine and with health concerns about smoking. In the 1960s the companies honestly grappled with difficult technical issues, and the goal of a safe cigarette seemed within reach. By the 1980s, the documents were filled with defensiveness and concerns about potential regulations, public relations, and products liability.

References

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