U.S. Government Accounting Office (GAO) 2003 Davis 1989 Philip Morris 1990b 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 Bero 2003 Malone and Balbach 2000 http://legacy.library.ucsf.edu Table 1 Zeltner et al. 2000 Hill 1993 Yin 1994 Table 2 Pesticides and Tobacco U.S. GAO 2003 U.S. GAO 2003 U.S. GAO 2003 Methoprene Manzelli 1975 Manzelli 1975 Philip Morris 1988 Seligman 1982 Ryan 1991 Lindahl 1992b Hutney 1991 Ryan 1992 Greenberg and Transon 1992 McCuen 1992 Hutney 1991 Hutney 1991 Hutney 1991 Lindahl 1992b sic Lindahl 1992b sic Lindahl 1992a Lindahl 1992c Mueller and Ward 1998 Greenberg and Transon 1992 Kemna 1991 Philip Morris 1991c Philip Morris 1991a Mueller 1991 Philip Morris 1991a CECCM 1991 1992a 1992b 1992c 1992d 1992e Philip Morris 1991b Mitchell 1991b Mitchell 1991a Mitchell 1991a Mitchell 1991a Philip Morris 1992 Philip Morris 1992 Philip Morris 1992 Philip Morris 1992 Reynolds 1993 Philip Morris 1995 European Union 2004 EBDC Fungicides U.S. EPA 1987 U.S. EPA 1989 Arce 1989 Centre de Coopération pour les Recherches Scientifiques Relatives au Tabac (CORESTA) 1989b Mitchell 1990 Philip Morris 1990a CORESTA 1989a 1989b CORESTA 1990b Zeltner et al. 2000 Zeltner et al. 2000 Reif 1991b CORESTA 1990a Beuchat 1990 Reif 1990 Vettorazzi 1991a Reif 1991a Vettorazzi 1991b Vettorazzi 1991b CORESTA 1992 Zeltner et al. 2000 Herrman 1991 Vettorazzi 1991c 1992a Herrman 1992 Vettorazzi 1992b Vettorazzi 1992b Zeltner et al. 2000 Zeltner et al. 2000 Black 1993 CORESTA 1994 Mueller 1993 Zeltner et al. 2000 CORESTA 1993 CORESTA 1993 CORESTA 2001 Phosphine U.S. EPA 1998b Garry et al. 1989 1993 Heyndrickx et al. 1976 Schoonbroodt et al. 1992 Wilson et al. 1980 U.S. EPA 1998b U.S. EPA 1998a Ward 1999 Harrell 1999 Seckar 1999c Reynolds 1999a Degesch America 1998 Reynolds 1999d Goldman 1998 Lyon 1999 Reynolds 1999b 1999c Lyon 1999 Ong and Glantz 2001 Seckar 1999h Sciences International 2005 Anderson 1999c Seckar 1999a Sciences International 1999c Seckar 1999a 1999b Seckar 1999a Seckar 1999a Bair 1999 Seckar 1999d Turim 1999 Anderson (1999b) My experience is that consultant reports funded by those being regulated, and written expressly for the EPA, are easily and frequently ignored or dismissed by the Agency, no matter how scholarly. However, a paper or article that is peer-reviewed and published, or in the peer review process for publication, in an accepted scientific journal can neither be ignored nor dismissed. Risk Analysis Anderson 1999b Seckar 1999e Risk Analysis Pepelko et al. 2004 Seckar 1999g Ward and Cowan 1999 Bridges 1995 Bridges 1995 Sciences International 1999a Wilkinson 1999 Wilkinson 1999 Barolo 1999a Sciences International 1999b Sciences International 1999b Seckar 1999f Whalan 1999 Whalan 1999 He also pointed out that Sciences International’s review of animal studies, intended to show that phosphine toxicity was relatively constant across species, was largely “irrelevant” because it did not include a comparison of toxicity for a small versus large mammal. Seckar 1999i Seckar 1999i Seckar 1999i Anderson 1999a Gray 1999 Barolo 1999b Barolo 1999c Sharp 1999 Federal Register U.S. EPA 2001 U.S. EPA 2000 U.S. EPA 2000 Sharp 1999 R.J. Reynolds 2000 Conclusion Abraham 2002 Huff 2002 Liberman 2002 Despite these limitations, the case studies discussed here provide insight into tactics that the tobacco industry applies to a regulatory agency when trying to influence the outcome of a decision. These tactics go significantly beyond the usual approaches—such as participation in public comment periods and public meetings—to influence scientific and regulatory decision making. Tobacco industry tactics described in these cases include: Encouraging a chemical company (Zoecon) to advocate for high MRLs without any supporting data and directing that same company to gather information about international regulatory efforts on methoprene in a manner designed to hide the interest of the tobacco industry in this chemical; Attempting to forestall regulatory efforts on tobacco pesticides in the European Community by creating voluntary industry MRLs for a subset of chemicals; Hiring an ex-WHO scientist to participate (without disclosing his funding source) in the WHO regulatory effort on EBDCs; Hiring several ex-U.S. EPA scientists to influence the U.S. EPA’s regulatory decision making on phosphine; a priori Staging fumigations for the U.S. EPA with the knowledge that the methodology was flawed and the results would show no emissions problem. Yet, as the case of European MRLs showed, the tobacco industry does not always work together effectively to influence regulations. Tobacco companies may disagree about regulatory strategies or conclude that inaction is preferable to action that might have unintended consequences. Moreover, the fact that even voluntary, industry-friendly pesticide guidelines posed significant problems for Philip Morris underscores tobacco industry motivation for resisting or influencing more stringent, government-imposed regulations. Federal Advisory Committee Act 1972 Registration Standards 2004 Special Review Procedures 2002 Protection of the public interest hinges on an open process and regulatory agencies’ willingness to stand up to pressure from regulated industries. When these are in doubt, public confidence in the fairness and efficacy of regulations may be unwarranted. The resource disparities between powerful industries and public health organizations may also make it difficult to ensure that the public interest is fairly represented, particularly when discussions occur behind closed doors, as apparently occurred at the U.S. EPA. Increased public and media scrutiny of these processes could help ensure that public health considerations are weighed at least as heavily as commercial ones. WHO 2004