Tobacco is a heavily pesticide-dependent crop. Because pesticides involve human safety and health issues, they are regulated nationally and internationally; however, little is known about how tobacco companies respond to regulatory pressures regarding pesticides. In this study we analyzed internal tobacco industry documents to describe industry activities aimed at influencing pesticide regulations. We used a case study approach based on examination of approximately 2,000 internal company documents and 3,885 pages of U.S. Environmental Protection Agency documents obtained through Freedom of Information Act requests. The cases involved methoprene, the ethylene bisdithiocarbamates, and phosphine. We show how the tobacco industry successfully altered the outcome in two cases by hiring ex-agency scientists to write reports favorable to industry positions regarding pesticide regulations for national (U.S. Environmental Protection Agency) and international (World Health Organization) regulatory bodies. We also show how the industry worked to forestall tobacco pesticide regulation by attempting to self-regulate in Europe, and how Philip Morris encouraged a pesticide manufacturer to apply for higher tolerance levels in Malaysia and Europe while keeping tobacco industry interest a secret from government regulators. This study suggests that the tobacco industry is able to exert considerable influence over the pesticide regulatory process and that increased scrutiny of this process and protection of the public interest in pesticide regulation may be warranted. Key words: ethylene bisdithiocarbamates, Environmental Protection Agency, methoprene, pesticide regulation, phosphine, tobacco industry, World Health Organization. Environ Health Perspect 113:1659-1665 (2005). doi:10.1289/ehp.7452 available via http://dx.doi.org/ [Online 8 August 2005]
Tobacco is a pesticide-intensive crop. With nearly 27 million pounds of pesticides (including insecticides, herbicides, fungicides, and suckercides) applied to the U.S.-grown crop from 1994 to 1998, it ranks sixth in terms of the amount of pesticides applied per acre [U.S. Government Accounting Office (GAO) 2003]. The tobacco industry regards pesticides as essential to tobacco production, stating that "the crop could not be produced economically without them" (Davis 1989; Philip Morris 1990b). According to industry documents, government-imposed limitations on pesticide use "may present a serious impediment" to the international tobacco trade (Hill 1989).
Internal tobacco industry documents provide a window into the tobacco industry's activities regarding pesticide regulations. These case studies drawn from industry documents describe the tobacco industry's responses to pesticide regulatory action. The documents also provide insight into the relationships between the tobacco industry and pesticide regulatory agencies and tensions between business and public health interests.
The Tobacco Industry Documents
Litigation against the tobacco industry has resulted in the release of nearly 7 million previously secret tobacco industry documents (Bero 2003; Malone and Balbach 2000). Scanned PDF versions of original handwritten, typed, or printed documents have been archived at the University of California, San Francisco, library in electronic repositories, searchable using basic keywords (http://legacy.library.ucsf.edu). Between July 2003 and February 2004, we searched the archives using a "snowball" sampling strategy, beginning with broad search terms ("pesticide" and "crop protection agent") and using retrieved documents to identify more specific search terms (such as names of specific pesticides, people, and regulatory agencies). Table 1 provides examples of keyword searches and the number of documents yielded. This process produced nearly 300,000 documents relating to many different pesticides. The first author reviewed these documents' index entries and excluded duplicates and documents unrelated to pesticide regulatory issues. The final sample size was approximately 2,000 documents, spanning 1974-2001.
We also filed Freedom of Information Act (FOIA) requests with the U.S. Environmental Protection Agency (EPA) on pesticide issues raised by information in the industry documents, resulting in 3,885 pages of government documents. Finally, we reviewed public health agency reports based on industry documents (Zeltner et al. 2000). We analyzed the industry, government, and public health agency documents by assembling chronologically constructed case studies, a method common to sociology, political science, and anthropology (e.g., analyses of a corporation's organizational structure, a social movement, or a tribe) (Hill 1993; Yin 1994) (Table 2). The pesticides chosen for inclusion [methoprene, the ethylene bisdithiocarbamates (EBDCs), and phosphine] were those for which sufficient information related to regulatory activities was available in the archives to construct a case study.
Pesticides and Tobacco
Pesticides used on tobacco are also used regularly on food crops. As with food crops, trace amounts of pesticides remain on tobacco leaves after treatment; typically, residue levels decline during the drying and manufacturing process, although additional pesticides may be applied to the finished product (U.S. GAO 2003). Although pesticides increase production of tobacco and food crops, pesticide exposure may harm humans; thus, regulatory agencies such as the U.S. EPA may set limits on the amount of pesticide residue permitted in or on food and tobacco and establish standards for workers handling pesticides. Because tobacco is burned and the smoke inhaled, active and passive smokers are exposed to pyrolyzed pesticide residues (U.S. GAO 2003). The U.S. EPA has concluded that this exposure poses no short-term risk, but little is known about the long-term health effects (U.S. GAO 2003).
In 1974, Philip Morris formed a partnership with the chemical company Zoecon to market a new insecticide (Manzelli 1975). The insecticide's active ingredient, methoprene, acted as an endocrine disruptor in cigarette beetles and tobacco moths, preventing their larvae from maturing into adult insects (Manzelli 1975). Philip Morris anticipated that methoprene would replace phosphine, a common warehouse fumigant (Philip Morris 1988) and pledged to assist Zoecon in introducing methoprene "in as many countries as we can" (Seligman 1982).
Some countries have regulations that require the establishment of maximum residue limits (MRLs) for pesticides on crops; however, Philip Morris determined that MRLs were not required in all countries, especially for pesticides on nonfood crops such as tobacco (Ryan 1991). Philip Morris asked Zoecon "to not force this issue and submit for MRLs when not required" (Lindahl 1992b). In April 1991 Zoecon alerted Philip Morris's director of research that the Malaysian pesticide board had recently set an MRL of 1.0 ppm for methoprene on tobacco (Hutney 1991). Zoecon considered 1.0 ppm too low to enable the effective use of methoprene; the level supported by the labeled application rate was 10 ppm (Ryan 1992). Philip Morris requested that Zoecon ask for an even higher MRL of 15 ppm to allow for application errors (Greenberg and Transon 1992; McCuen 1992). Zoecon representatives met with government authorities and requested a change to 15 ppm (Hutney 1991).
A Zoecon representative informed Philip Morris that "in order to avoid surprises of this nature in the future," he had directed Zoecon's pharmaceutical group to obtain information from health authorities in other countries regarding the commodities for which methoprene tolerances were assigned (which could include foods such as rice and mushrooms as well as tobacco) (Hutney 1991). Assigning this task to the pharmaceutical group instead of the pesticide group, the Zoecon representative wrote, "will not arouse the curiosity of the health directorates and will allow us to keep our promise to the tobacco industry, namely, that we won't initiate queries that may cause the health authorities to direct attention to tobacco" (Hutney 1991).
In April 1992, George Lindahl of Zoecon faxed a letter to Bob McCuen, head of Philip Morris's biochemical research, outlining some of his concerns about Philip Morris's approach to establishing MRLs for methoprene on tobacco (Lindahl 1992b). In regard to Zoecon's effort to establish an MRL of 15 ppm in Malaysia, Lindahl explained that
I know we simply argued this case without any data to support our request. In more advanced countries, this tactic will not succeed.... All our data demonstrate the need for a 10 ppm MRL. If a higher value is desired then we will require data from real field operations showing that a worse [sic] case scenario for faulty application will result in a 15 ppm residue, and hence the need for this value. (Lindahl 1992b)
In a fax following this one, Lindahl asked Philip Morris to provide such data; a handwritten comment from a Philip Morris employee who reviewed the fax noted that "data doesn't [sic] exist" (Lindahl 1992a). Initially, the Malaysian authorities agreed to increase methoprene's MRL to 10 ppm (Lindahl 1992c); subsequently, it was raised to 15 ppm (Mueller and Ward 1998). Philip Morris continued to advocate (through Zoecon) for MRLs of 15 ppm in Italy and Germany (Greenberg and Transon 1992).
In the meantime, anticipating the creation of a single European market with uniform pesticide regulations, Philip Morris had asked the longtime tobacco industry law firm, Shook, Hardy, and Bacon, to prepare a document with MRL recommendations for possible submission to the European Community (Kemna 1991). Philip Morris first provided a draft of …