The process of identifying carcinogens for purposes of health and safety regulation has been contested internationally. The U.S. government produces a “Report on Carcinogens” every two years, which lists known and likely human carcinogenic substances. In the late 1990s the tobacco industry responded to the proposed listing of secondhand smoke with a multi-part strategy. Despite industry efforts to challenge both the substance of the report and the agency procedures, environmental tobacco smoke was declared by the agency in 2000 to be a known human carcinogen. A subsequent lawsuit, launched by chemical interests but linked to the tobacco industry, failed, but it produced a particular legal precedent of judicial review that is favorable to all regulated industries. The authors argue that, in this case, tobacco industry regulation contradicts academic expectations of business regulatory victories. However, the tobacco industry's participation in the regulatory process influenced the process in favor of all regulated industry.
Get full access to this article
View all access options for this article.
References
1.
European Environment Agency. Late Lessons from Early Warnings: The Precautionary Principle 1896–2000.Copenhagen, January 10, 2002.
2.
EpsteinS. S.REACH: An unprecedented European initiative for regulating industrial chemicals. Int. J. Health Serv.35(1):1–38, 2005.
3.
National Toxicology Program. Report on Carcinogens, Eleventh Edition.U.S. Department of Health and Human Services, Public Health Service, Washington, DC, January 31, 2005.
4.
CoglianoV. J.Current criteria to establish human carcinogens. Semin. Cancer Biol.14:407–412, 2004.
5.
BarnardR. C.MoolenaarR. J., and StevensonD. E.IARC and HHS Lists of carcinogens: Regulatory use based on misunderstanding of the scope and purpose of the lists. Regul. Toxicol. Pharmacol.9:81–97, 1989.
6.
EpsteinS. S.The crisis in U.S. and international cancer policy. Int. J. Health Serv.32(4):669–707, 2002.
7.
BeroL. A., and GlantzS. A.Tobacco industry response to a risk assessment of environmental tobacco smoke. Tobacco Control1993(2):103–113, 1993.
8.
Bryan-JonesK., and BeroL. A.Tobacco industry efforts to defeat the Occupational Safety and Health Administration indoor air quality rule. Am. J. Public Health93(4):585–592, 2003.
9.
StiglerG. J.The Citizen and the State.University of Chicago Press, Chicago, 1975.
10.
BaumgartnerF. R., and LeechB. L.Basic Interests: The Importance of Groups in Politics and in Political Science.Princeton University Press, Princeton, NJ, 1998.
11.
MarkowitzG., and RosnerD.Deceit and Denial: The Deadly Politics of Industrial Pollution.University of California Press, Berkeley, 2002.
12.
MartinC. J.Stuck in Neutral: Business and the Politics of Human Capital Investment Policy.Princeton University Press, Princeton, NJ, 2000.
13.
FritschlerA. L., and HoeflerJ. M.Smoking and Politics: Policy Making and the Federal Bureaucracy, Ed. 5. Prentice Hall, Upper Saddle River, NJ, 1996.
14.
BeroL. A.Science in regulatory policy making: Case studies in the development of workplace smoking restrictions. Tobacco Control10:329–336, 2001.
15.
SmithM. A.American Business and Political Power.University of Chicago Press, Chicago, 2000.
16.
StudlarD. T.Tobacco Control: Comparative Politics in the United States and Canada.Broadview Press, Peterborough, Ont., 2002.
17.
SchroederS. A.The tobacco buyout and the FDA. N. Engl. J. Med.351(14):1377–1380, 2004.
18.
MajoneG.Evidence, Argument, and Persuasion in the Policy Process.Yale University Press, New Haven, 1989.
19.
CarpenterD. P.Protection without capture: Product approval by a politically responsive, learning regulator. Am. Polit. Sci. Rev.98(4):613–631, 2004.
20.
EisnerM. A.Regulatory Politics in Transition.Johns Hopkins University Press, Baltimore, 1993.
21.
Flue-Cured Tobacco Cooperative v. EPA.Judge Widener, U.S. Court of Appeals Fourth Circuit, Richmond, VA, 2002.
22.
SchotlandM., and BeroL.Evaluating public commentary and scientific evidence submitted in the development of a risk assessment. Risk Analysis22(1):131–140, 2002.
23.
OngE. K., and GlantzS. A.Tobacco industry efforts subverting International Agency for Research on Cancer's second-hand smoke study. Lancet355:1253–1259, 2000.
24.
HuffJ.IARC monographs, industry influence, and upgrading, downgrading, and under-grading chemicals: A personal point of view. Int. J. Occup. Environ. Health8(3):249–261, 2002.
25.
LiangY.New trends in the development of occupational exposure limits for airborne chemicals in China. Regul. Toxicol. Pharmacol.38:112–123, 2003.
26.
CoglianoV. J.The science and practice of carcinogen identification and evaluation. Environ. Health Perspect.112(13):1269–1274, 2004.
HiilamoH. T.Tobacco control implications of the first European product liability suit. Tobacco Control14:22–30, 2005.
30.
MontfortJ.-P.The Commission White Paper on a strategy of a future EU chemicals policy: The view of European companies of American parentage. Risk Analysis23(2):399–404, 2003.
31.
DurodieB.The true cost of precautionary chemicals regulation. Risk Analysis23(2):389–398, 2003.
32.
DerthickM., and QuirkP. J.The Politics of Deregulation.Brookings Institution, Washington, DC, 1985.
33.
BeroL.Implications of the tobacco industry documents for public health and policy. Annu. Rev. Public Health24:267–288, 2003.
Moure-ErasoR.Primary prevention and precaution in hazard identification in the NIEHS/NTP: Body in the morgue approach. Public Health Rep.117(6):564–573, 2002.
42.
BergesonL. L., and CampbellL. M.The Tozzi decision: Another arrow in manufacturers' quiver in product defense wars. EPA Administrative Law Reporter18(5):573–580, 2001.
43.
InfanteP. F.Safeguarding scientific evaluations by governmental agencies: Case study of OSHA and the 1,3-butadiene classification. Int. J. Occup. Environ. Health11(4):372–377, 2005.
44.
OrloffK.Memo to Charles Nystrom: Benzene in Cigarette Smoke. July 1, 1982. RJ Reynolds. Bates No. 503245866/5867. http://legacy.library.ucsf.edu/tid/nnc68d00 (February 23, 2004).
45.
Shook Hardy & Bacon. Brief Overview of Status. December 17, 1997. Philip Morris. Bates No. 2063601066/1068. http://legacy.library.ucsf.edu/tid/bko67e00 (February 23, 2004).
KlugerR.Ashes to Ashes: America's Hundred-Year Cigarette War, the Public Health, and the Unabashed Triumph of Philip Morris.Vintage Books, New York, 1996.
CinkJ.HenryC., and SchultzF.Letter, Contract/Agreement. January 24, 1986. Lorillard. Bates No. 87695121/5125. http://legacy.library.ucsf.edu/tid/hap21e00 (February 23, 2004).
54.
National Toxicology Program. List of 5 Minute Public Presentations. December 2, 1998. Philip Morris. Bates No. 2063906240/6243. http://legacy.library.ucsf.edu/tid/pnk77d00 (February 23, 2004).
55.
OsborneK.Worldwide Scientific Affairs. Fax: Draft for in the Loop. December 29, 1998. Philip Morris. Bates No. 2071826017. http://legacy.library.ucsf.edu/tid/bqo06c00 (February 23, 2004).
56.
LevyP.This Is to Request Permission to Make a Presentation. November 25, 1998. RJ Reynolds. Bates No. 521107905/7905. http://legacy.library.ucsf.edu/tid/mnz20d00 (February 23, 2004).
57.
WellsA. J.Lung cancer from passive smoking at work. Am. J. Public Health88(7):1025–1029, 1998.
58.
American Industrial Health Council. Agenda Spc/Sc NTP Discussion. September 23, 1998. Philip Morris. Bates No. 2063593136/3140. http://legacy.library.ucsf.edu/tid/ktp67e00 (February 23, 2004).
59.
OSHA. Safety and Health Topics: 1,3-Butadiene.Washington DC, 2002. www.osha.gov/SLTC/butadiene/ (March 9, 2005).
60.
ManuelJ.NIEHS news: Ninth ROC rocks the boat. Environ. Health Perspect., January 1999.
61.
National Institute of Environmental Health Sciences. Dioxin Research at the National Institute of Environmental Health Sciences.Research Triangle Park, NC, November 18, 2002. www.niehs.nih.gov/oc/factsheets/dioxin.htm (March 9, 2005).
Multinational Business Services. Upholding Standards for Data Quality in Regulatory Decision Making: Procedural Violations in the National Toxicology Program's Report on Carcinogens Program. January 25, 1999. Philip Morris. Bates No. 2072724622/4644. http://legacy.library.ucsf.edu/tid/tii42c00 (February 23, 2004).
FestaJ.NTP Report on Carcinogens—Classification of Dioxin. March 18, 1999. Philip Morris. Bates No. 2074593677/3678. http://legacy.library.ucsf.edu/tid/mcm66c00 (February 23, 2004).
70.
Center for Regulatory Effectiveness. The Report on Carcinogens Program. June 1999. Philip Morris. Bates No. 2072535800/5897. http://legacy.library.ucsf.edu/tid/gad42c00 (February 23, 2004).
BuschJ.American Forest and Paper Association. Ninth Report on Carcinogens. August 13, 1999. Philip Morris. Bates No. 2505614684/4687. http://legacy.library.ucsf.edu/tid/pun47c00 (February 23, 2004).
CarchmanR.A Summary of “Critical Analysis and Scientific Judgment in the Draft Background Document.” September 15, 1999. Philip Morris. Bates No. 2074942944/2946. http://legacy.library.ucsf.edu/tid/tzp52c00 (February 23, 2004).
76.
Washington in Brief. Washington Post, May 16, 2000.
77.
BircherA.EdwardsD., and CarlyleW.Letter Regarding Draft Memorandum. July 5, 2000. RJ Reynolds. Bates No. 525460680/0680. http://legacy.library.ucsf.edu/tid/wlo20d00 (February 23, 2004).
78.
StamJ. H., and RoederL.Federal court affirms HHS classification of dioxin as “known” human carcinogen. Daily Environ. Report, November 26, 2001.
79.
RaulA. C., and ZampaJ. M.Deeper judicial scrutiny needed for agencies' use of science. Washington Legal Foundation Legal Backgrounder17(7), 2002.
80.
OngE., and GlantzS.Constructing “sound science” and “good epidemiology”: Tobacco, lawyers, and public relations firms. Am. J. Public Health91(11):1749–1757, 2001.
81.
Civil Actions. Legal Times, May 24, 1999.
82.
Federal focus. Opportunities for Interacting with Federal Agency scientists on Regulatory Issues. May 1999. Philip Morris. Bates No. 2505486949/6978. http://legacy.library.ucsf.edu/tid/ifb05c00 (March 5, 2004).
83.
Poyner, Spruill. D.C. Circuit broadens standing and reviewability in dioxin case. North Carolina Environ. Law Letter12(7), 2001.
84.
CoglianeseC.Litigating within relationships: Disputes and disturbance in the regulatory process. Law and Society Rev.30(4):735–766, 1996.
Center for Regulatory Effectiveness. CRE and Grower Groups File Data Quality Act Petition on NTP RoC Procedures. June 30, 2004. www.thecre.com/quality/20040630_regweek.html (July 20, 2004).
87.
WeissR.“Data quality” law is nemesis of regulation. Washington Post, August 16, 2004.
88.
BabaA.Legislating sound science regulation: The role of the tobacco industry. Am. J. Public Health95(7s):S20–S27, 2005.
89.
RepaceJ.Personal communication, 2005.
90.
PivenF. F., and ClowardR. A.Poor Peoples' Movements: Why They Succeed, How They Fail.Pantheon Books, New York, 1977.
91.
JacobsonP., and BanerjeeA.Social movements and human rights rhetoric in tobacco control. Tobacco Control, 14(suppl. II):ii45–ii49, 2005.
92.
SchmidtP.Pursuing regulatory relief: Strategic participation and litigation in U.S. OSHA rulemaking. Business and Politics4(1):71–89, 2002.
93.
ShapiroM.Who Guards the Guardians? Judicial Control of Administration.University of Georgia Press, Athens, 1988.
94.
NeumanM.BittonA., and GlantzS.Tobacco industry strategies for influencing European Community tobacco advertising legislation. Lancet359:1323–1330, 2002.
95.
EpsteinS. S.Legislative proposals for reversing the cancer epidemic and controlling run-away industrial technologies. Int. J. Health Serv.30(2):353–371, 2000.
