Hostname: page-component-cd9895bd7-jn8rn Total loading time: 0 Render date: 2024-12-27T06:42:59.492Z Has data issue: false hasContentIssue false
  • English
  • Français

Environment and Health: Vital Intersection or Contested Territory?

Published online by Cambridge University Press:  06 January 2021

Richard W. Clapp  and
David Ozonoff
Richard W. Clapp
Affiliation:
Department of Environmental Health at the Boston University School of Public Health
David Ozonoff
Affiliation:
Department of Environmental Health at the Boston University School of Public Health
Get access Rights & Permissions [Opens in a new window]

Extract

The effects of environmental exposure, broadly defined as any exposure from outside the body, on human health are unquestionably the most important determinants of public health. While important genetic determinants of disease exert their effects irrespective of exposure from outside the body, these do not contribute as much to the overall public health burden of disease as factors such as tobacco smoke, poor quality water, inadequate or contaminated food, occupational exposures to dusts and chemicals, motor vehicle accidents, interpersonal violence, air pollution, and other factors external to the body. In many cases, genetic predisposition and environmental exposures combined cause disease in an individual, so it may be impossible to separate out individual biological contributions from various external factors. Nevertheless, it is widely understood that public health concerns populations and communities, and that environmental determinants of health have been paramount throughout human history.

Type
Article
Information
American Journal of Law & Medicine , Volume 30 , Issue 2-3 , June 2004 , pp. 189 - 215
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2004

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1 See THE GLOBAL BURDEN OF DISEASE: A COMPREHENSIVE ASSESSMENT OF MORTALITY AND DISABILITY FROM DISEASES, INJURIES, AND RISK FACTORS IN 1990 AND PROJECTED TO 2020 27 (Christopher J. L. Murray & Alan D. Lopez eds., 1996). This ongoing work ascribes the highest proportion of disease and disability to malnutrition, followed by poor water supply and poor sanitation.

2 See Francine, A. Hochberg, Note, HIV/AIDS and Blood Donation Policies: A Comparative Study of Public Health Policies and Individual Rights Norms, 12 DUKE J. COMP & INTL L. 231, 233 (2002)Google Scholar.

3 For a detailed summary of Dr. Snow's research and contributions to epidemiology, see RALPH R. FRERICHS, JOHN SNOW, at http://www.ph.ucla.edu/epi/snow.html (last visited July 19, 2004).

4 Snow conducted his research before the germ theory of disease became the predominate causation theory. See id.

5 Peter, F. Lake & Joel, C. Epstein, Modern Liability Rules and Policies Regarding College Student Alcohol Injuries: Reducing High-Risk Alcohol Use Through Norms of Shared Responsibility and Environmental Management, 53 OKLA. L. REV. 611, 622 (2000)Google Scholar.

6 See COUNCIL ON EDUCATION FOR PUBLIC HEALTH, ACCREDITATION CRITERIA: GRADUATE SCHOOLS OF PUBLIC HEALTH, at http://www.ceph.org (last updated June 2004).

7 See Neil Pearce, Traditional Epidemiology, Modern Epidemiology, and Public Health. 86 AM. J. PUBL. HEALTH 678 (1996). Pearce derides the narrowness of much modern epidemiology and calls for a return to the broad, population-based and action-oriented approach that gave the field its credibility.

8 See ENVIRONMENTAL TOXICANTS: HUMAN EXPOSURES AND THEIR HEALTH EFFECTS (Morton Lippmann ed., 2d ed. 2000)

9 See, e.g., In re Agent Orange Prod. Liab. Litig., 611 F. Supp. 1223 (E.D.N.Y. 1985); City- Wide Coalition Against Childhood Lead Paint Poisoning v. Philadelphia Housing Authority, 356 F. Supp. 123 (D. Pa. 1973); Ecumenical Task Force of Niagara Frontier, Inc. v. Love Canal Area, 179 A.D.2d 261 (N.Y. App. Div. 1992).

10 In re Agent Orange Prod. Liab. Litig., 611 F. Supp. at 1223.

11 509 U.S. 579, 589(1993); see also Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137-147- 50 (1999); General Electric Co. v. Joiner, 522 U.S. 136, 141-43 (1997). These three cases are sometimes called the Daubert trilogy and are the basis for the current judicial review of scientific evidence in toxic torts, especially at the Federal level, but in many State courts, as well. The full text of the Daubert decision and accompanying commentary can be found at http://www.defendingscience.org (last visited July 19, 2004).

12 See Jean Macchiaroli Eggen, Toxic Torts, Causation, and Scientific Evidence After Daubert, 55 U. PITT. L. REV. 889, 896 (1994) (discussing plaintiffs difficulties of satisfying the preponderance of evidence standard in tort cases using scientific evidence); Michael, H. Gottesman, From Barefoot to Daubert to Joiner: Triple Play or Double Error, 40 ARIZ L. REV. 753, 761 (1998)Google Scholar (indicating that in some jurisdictions, plaintiffs must provide evidence of causation to a high degree of certainty in order to avoid dismissal).

13 See Goebel v. Denver & Rio Grande W. R.R. Co. , 215 F.3d 1083, 1087 (10th Cir. 2000) (It is within the discretion of the trial court to determine how to perform its gatekeeping function under Daubert.) (emphasis in original).

14 See Jerome O. Nriagu, Historical Perspective on the Contamination of Food and Beverages with Lead, in DIETARY AND ENVIRONMENTAL LEAD: HUMAN HEALTH EFFECTS 1, 1-4 (Kathryn R. Mahaffey ed., 1985).

15 Id. at 30-31.

16 Jane S. Lin-Fu, Historical Perspective on Health Effects of Lead, in DIETARY AND ENVIRONMENTAL LEAD: HUMAN HEALTH EFFECTS 51, 51-52 (Kathryn R. Mahaffey ed., 1985).

17 Id. at 52-55.

18 J., Julian Chisolm Jr. et al., Dose-Effect and Dose-Response Relationship for Lead in Children, 87 J. PEDIATRICS 1152 (1975)Google Scholar.

19 Id.

20 Id.

21 H. L., Needleman et al., Deficits in Psychologic and Classroom Performance of Children With Elevated Dentine Lead Levels, 300 NEW ENG. J. MED. 689, 694 (1979)Google Scholar. Dr. Needleman and colleagues have been at the forefront in identifying health and behavioral consequences of childhood lead exposure. The current assessment is that there is no safe threshold below which there are no adverse effects. Id.

22 CENTER FOR DISEASE CONTROL, U.S. DEPARTMENT OF HEALTH, EDUCATION AND WELFARE, PREVENTING LEAD POISONING IN YOUNG CHILDREN (1978), available at http://www.cdc.gov/nceh/lead/publications/pub_Reas.htm.

23 CENTERS FOR DISEASE CONTROL AND PREVENTION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, PREVENTING LEAD POISONING IN YOUNG CHILDREN ch. 3 (1991), available at http://www.cdc.gov/nceh/lead/publications/books/plpyc/chapter3.htm [hereinafter CDC PREVENTING LEAD POISONING].

24 Cushing N. Dolbeare & Don Ryan, Getting the Lead Out: Controlling Lead Paint Hazards in Housing (Sept./Oct. 1997), available at http://www.nhi.org/online/issues/95/lead.html.

25 See Jane, Schukoske, The Evolving Paradigm of Laws on Lead-Based Paint: From Code Violation to Environmental Hazard, 45 S.C. L. REV. 511, 545 (1994)Google Scholar.

26 See id. at 527, 540-44.

27 MASSACHUSETTS DEPARTMENT OF PUBLIC HEALTH, CHILDHOOD LEAD POISONING PREVENTION PROGRAM, MASSACHUSETTS FIGHT AGAINST LEAD POISONING: UPDATED TRENDS, 1993-1998 (1999), available at http://www.state.ma.us/dph/clppp/ledstats.htmmaps.

28 Id.

29 Id.

30 MARY JEAN BROWN ET AL., SMALL AREA ANALYSIS OF RISK FOR CHILDHOOD LEAD POISONING 4 (2001), available at http://www.afhh.org/res/res_publications.htm.

31 Henry, Falk, International Environmental Health for the Pediatrician: Case Study of Lead Poisoning, 112 PEDIATRICS 259 (2003)Google Scholar.

32 Id.

33 See, e.g., David, Rosner & Gerald, Markowitz, A Gift of God?: The Public Health Controversy over Leaded Gasoline During the 1920s, 75 AM. J. PUB. HEALTH 344 (1985)Google Scholar.

34 42 U.S.C. 7545 (2000).

35 16 C.F.R. 1303 (2003).

36 CENTER FOR DISEASE CONTROL, U.S. DEPARTMENT OF HEALTH, EDUCATION & WELFARE, INCREASED LEAD ABSORPTION AND LEAD POISONING IN YOUNG CHILDREN (1975), available at http://www.cdc.gov/nceh/lead/publications/pub_Reas.htm.

37 Pamela A. Meyer et al., Surveillance for Elevated Blood Lead Levels Among Children United States, 1997-2001, MORBIDITY & MORTALITY WEEKLY REP., Sept. 12, 2003, at 2.

38 Id. at 1.

39 CDC, DHHS, CHILDREN's BLOOD LEVELS IN THE UNITED STATES, at http://www.cdc.gov/nceh/lead/research/kidsBLL.htm (last reviewed Mar. 12, 2003).

40 Id.

41 Id.

42 MASS. GEN. LAWS ch. 111, 189A-199B (2003).

43 MASS. REGS. CODE tit. 105, 460.080 (2001).

44 See infra notes 45-46 and accompanying text.

45 Azell Murphy Cavaan, 4 Win 4 Million in Paint Lawsuit, REPUBLICAN, Sept. 16, 2003, at A1.

46 David, Rosner & Gerald, Markowitz, Industry Challenges to the Principle of Prevention in Public Health: The Precautionary Principle in Historical Perspective, 117 PUB. HEALTH REP. 501, 502-05 (2002)Google Scholar.

47 Current concerns about endocrine-disrupting chemicals and persistent organic pollutants have many of the earmarks of the lead paint and leaded gasoline stories of the past century. See, e.g., Julie Wakefield, Boys Won't Be Boys, NEWSCIENTIST, June 29, 2002, at 42.

48 See, e.g., Richard, Clapp, Environment and Health: 4. Cancer, 163 CAN. MED. ASSN J. 1009, 1009 (2000)Google Scholar.

49 See ADELINE GORDON LEVINE, LOVE CANAL: SCIENCE, POLITICS AND PEOPLE (1982). Love Canal residents led a campaign to raise awareness about toxic threats to children's health that sparked a nationwide movement. Id. ch. 7, at 175.

50 See Steve, Wing et al., Mortality Among Workers at Oak Ridge National Laboratory: Evidence of Radiation Effects in Follow-Up Through 1984, 265 JAMA 1397, 1399 (1991)Google Scholar. This study was one of the first to show evidence of increased leukemia deaths in workers exposed to low-level ionizing radiation. Id.

51 See Pier, Alberto Bertazzi et al., Health Effects of Dioxin Exposure: A 20-Year Mortality Study, 153 AM. J. EPIDEMIOLOGY 1031 (2001)Google Scholar. This latest publication of the results shows increased deaths due to several malignant and nonmalignant diseases in those exposed to dioxin after the 1976 accident. Id.

52 See Denis, Bard et al., Chernobyl, 10 Years After: Health Consequences, 19 EPIDEMIOLOGIC REVIEWS 187 (1997)Google Scholar.

53 See E. Donald Elliott, Planning and Managing Mass Toxic Tort Cases, in ENVIRONMENTAL LITIGATION (Janet S. Kole & Larry D. Espel eds., 1991).

54 NATIONAL CANCER INSTITUTE, SEER CANCER STATISTICS REVIEW, 1973-2000 (L. A. G. Ries et al. eds., 2000), available at http://seer.cancer.gov/csr/1975_2000/sections.html.

55 Id.

56 Id. sec. 1, tbl. I-2.

57 See Cancer Epidemiology: New U.K. Cancer Statistics Released for Year 2000, CANCER WEEKLY, Jan. 27, 2004, available at 2004 WL 55262873.

58 Gynecological Cancer: Proteomics is the Newest, Most Promising Direction for Gynecologic Cancer, CANCER WEEKLY, Jan. 6, 2004, available at 2004 WL 55262326.

59 NATIONAL CANCER INSTITUTE, supra note 54, at sec. 1, tbl. I-2.

60 See Cancer Epidemiology: Global Cancer Rates Could Increase by 50% to 15 Million by 2020, CANCER WEEKLY, Apr. 29, 2003, available at 2003 WL 9045477.

61 See Skin Cancer: Sun Safety Alliance Discourages Sun Exposure for Vitamin D Deficiency, CANCER WEEKLY, Apr. 20, 2004, available at 2004 WL 55265266.

62 Cancer Incidence: Exposure to High Levels of Trichloroethylene May Increase Risk Of NHL, CANCER WEEKLY, Feb. 10, 2004, available at 2004 WL 55263223.

63 See Hannah, K. Weir et al., Annual Report to the Nation on the Status of Cancer, 1975 2000, Featuring the Uses of Surveillance Data for Cancer Prevention and Control, 95 J. NATL CANCER INST. 1276 (2003)Google Scholar.

64 See Philip, Cole & Brad, Rodu, Declining Cancer Mortality in the United States, 78 CANCER 2045 (1996)Google Scholar.

65 See NATIONAL CANCER INSTITUTE, supra note 54, at sec. 1, tbl. I-15.

66 Richard, Doll & Richard, Peto, The Causes of Cancer: Quantitative Estimates of Avoidable Risks of Cancer in the United States Today, 66 J. NATL CANCER INST. 1191 (1981)Google Scholar. This was the first major attempt to quantify the factors which contribute to cancer deaths in the United States and was cited for many years, even though it is restricted to white deaths under age sixty-five, or less than half of the total cancer deaths.

67 Id.

68 Harvard Center for Cancer Prevention, Harvard Report on Cancer Prevention, 7 CANCER CAUSES CONTROL S1 (1996). This analysis attempted to update the Doll and Peto analysis with more recent studies.

69 Id.

70 See Paul, B. Lipsky et al., Red Snapper or Crab?, 350 NEW ENG. J. MED. 1443 (2004)Google Scholar.

71 See Ragner, Rylander, Environmental Tobacco Smoke And Lung Cancer, 323 NEW ENG. J. MED. 834 (1990)Google Scholar.

72 Barbara, A. Gilchrest et al., The Pathogenesis of Melanoma Induced by Ultraviolet Light, 340 NEW ENG. J. MED. 1341 (1999)Google Scholar.

73 See Paul A. Scherr & Nancy E. Mueller, Non-Hodgkin's Lymphomas, in CANCER EPIDEMIOLOGY AND PREVENTION (David Schottenfeld & Joseph F. Fraumeni, Jr. eds., 2d ed. 1996).

74 Id.

75 See INTERNATIONAL AGENCY FOR RESEARCH ON CANCER, OVERALL EVALUATIONS OF CARCINOGENICITY TO HUMANS, at http://193.51.164.11/monoeval/crthgr01.html (last updated July 7, 2004).

76 See id.

77 See IARC, OESTROGENS, STEROIDAL, at http://193.51.164.11/htdocs/monographs/suppl7/oestrogenssteroidal.html (1987); IARC, STATIC AND EXTREMELY LOW-FREQUENCY (ELF) ELECTRIC AND MAGNETIC FIELDS (2002), at http://193.51.164.11/htdocs/monographs/vol80/80.html.

78 Ethel, S. Gilbert et al., Thyroid Cancer Rates and I-131 Doses from Nevada Atmospheric Nuclear Bomb Tests, 90 J. NATL CANCER INST. 1654 (1998)Google Scholar.

79 Frank, de Gruijl & Jan, van der Leun, Environment and Health: 3, Ozone Depletion and Ultraviolet Radiation, 163 CMAJ 851 (2000)Google Scholar.

80 JONATHAN HARR, A CIVIL ACTION (1995).

81 Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993).

82 The historical context of these guidelines is of interest: Sir Bradford Hill proposed his viewpoints in 1965, well before the International Agency for Research on Cancer (IARC) or U.S. agencies, such as the Environmental Protection Agency or Occupational Safety and Health Administration, had begun promulgating lists and categories of carcinogens. Further, Dr. Bradford Hill's own commentary on the use of his guidelines was most instructive; they are not meant to replace common sense and judgment but to aid them. Hill's viewpoints are further discussed in Part IV.B. of this Article.

83 JOHN STUART MILL, SYSTEM OF LOGIC: RATIOCINATIVE AND INDUCTIVE (Longman, Green, & Co. 1906).

84 Id. at 373-426.

85 Id.

86 Cf. id. at 437-47.

87 See Linda A. Bailey et al., Reference Guide on Epidemiology, in REFERENCE MANUAL ON SCIENTIFIC EVIDENCE 121, 129 (1994).

88 See U.S. GEOLOGICAL SURVEY, INTRODUCTION TO SEISMOLOGY, at http://quake.wr.usgs.gov/research/seismology/ (last modified Nov. 26, 2001).

89 See MILL, supra note 83, at 440.

90 See id. at 448-528.

91 Id. at 187.

92 MANUAL OF EPIDEMIOLOGY FOR DISTRICT HEALTH MANAGEMENT 9-10 (J. P. Vaughan & R. H. Morrow eds., 1989)

93 ENCYCLOPEDIA OF ANIMAL RIGHTS AND ANIMAL WELFARE (Marc Bekoff & Carron A. Meaney eds., 1998); NATIONAL HUMAN GENOME RESEARCH INSTITUTE, ABOUT THE HUMAN GENOME PROJECT, at http://www.genome.gov/10001772 (last updated June 2004).

94 PAWS N TAILS, ANIMAL TESTINGFACTS, at http://www.geocities.com/paws_n_tails/AnimalTestingFacts.html (last visited July 19, 2004).

95 For example, The Lancet, one of the world's leading medical journals, contains a Case Report every week. See, e.g., Kathryn, A. Tuohy et al., Agitation by Sedation, 361 LANCET 308 (2003)Google Scholar.

96 MILL, supra note 83.

97 See supra notes 88-90 and accompanying text.

98 Id.

99 MILL, supra note 83, at 256.

100 See generally ANN ASCHENGRAU & GEORGE R. SEAGE, ESSENTIALS OF EPIDEMIOLOGY IN PUBLIC HEALTH (2003) (discussing the foundations of epidemiology in public health).

101 Id.

102 Id.

103 Id.

104 David, Ozonoff, Conceptions and Misconceptions About Human Health Impact Analysis, 14 ENVTL. IMPACT ASSESSMENT REV. 499 (1994)Google Scholar.

105 See id. at 506-10.

106 Marion, K. Slack & Jolaine, R. Draugalis, Establishing the Internal and External Validity of Experimental Studies, 58 AM. J. HEALTH-SYSTEM PHARMACY 2173 (2001)Google Scholar.

107 Ozonoff, supra note 104.

108 See Slack & Draugalis, supra note 106.

109 David, P. Farrington, Assessing Systematic Evidence in Crime and Justice Methodological Concerns and Empirical Outcomes, 587 ANNALS 49 (2003)Google Scholar.

110 Id.

111 For instance, the sudden death of a worker exposed to hydrogen sulfide. Meg, Godfrey, Using PIDs in Confined Spaces, 73 OCCUPATIONAL HEALTH & SAFETY 40 (2004)Google Scholar.

112 See supra notes 89-90 and accompanying text.

113 See supra notes 105-07 and accompanying text.

114 Note that the analysis works just as well in a case where there is no increased disease.

115 See U.S. ENVIRONMENTAL PROTECTION AGENCY, DIOXIN REASSESSMENT REVIEW, sec. 4.5.1, at http://www.epa.gov/sab/pdf/ec95021.pdf (Sept. 29, 1995).

116 See id.

117 See id.

118 See, e.g., Bailey et al., supra note 87.

119 Id.

120 Id.

121 Id.

122 Id.

123 Epidemiologists often find that there are unanticipated problems or uncertainties in conducting epidemiologic studies, and that other epidemiologists usually are quick to point these out. As with most things, designing an informative study is difficult. Criticizing one is easy.

124 VICTOR J. SHOENBACH & WAYNE D. ROSAMOND, UNDERSTANDING THE FUNDAMENTALS OF EPIDEMIOLOGY: AN EVOLVING TEXT 13 (2000).

125 Id.

126 This is a deterministic view of disease causation. One could also take a probabilistic view, in which case scientists would have to discuss sample error from some assumed super-population of identical study settings. This alternative view does not affect any of the points made.

127 Id. at 49-50.

128 Id. at 50.

129 David, Egilman et al., Proving Causation: The Use and Abuse of Medical and Scientific Evidence Inside the CourtroomAn Epidemiologist's Critique of the Judicial Interpretation of the Daubert Ruling, 58 FOOD DRUG L.J. 223, 237 (2003)Google Scholar (Significance testing is a statistical technique used for evaluating the role of chance as a possible explanation for an observed association between cause and effect.) (emphasis added).

130 See id.

131 Troyen, A. Brennan, Causal Chains and Statistical Links: The Role of Scientific Uncertainty in Hazardous-Substance Litigation, 73 CORNELL L. REV. 469, 505 (1988)Google Scholar. The original source of the 5% criterion is lost in time. It apparently came from the original applications of statistical methods to agricultural experiments and expressed a cost-benefit statement about the expense of redoing a large trial involving a whole growing season and plots of various seeds and fertilizers. Its use for public health purposes might thus be questioned. It is interesting to note that in other sciences, notably, physics, another common criterion for statistical significance is not 5% but 10%. In any event, virtually every elementary statistics text warns the student of the highly arbitrary nature of the figure.

132 Barbara Frederick, Daubert v. Merrell Dow Pharmaceuticals, Inc.: Method or Madness?, 27 CONN. L. REV. 237, 241 n.27 (1994).

133 Robert, J. Lewis Jr., The Kansas Sentencing Guidelines Act, 38 WASHBURN L.J. 327, 340 (1999)Google Scholar.

134 Carl, F. Cranor et al., Judicial Boundary Drawing and the Need for Context-Sensitive Science in Toxic Torts After Daubert v. Merrell Dow Pharmaceuticals, Inc., 16 VA. ENVTL. L.J. 1, 32- 34 (1996)Google Scholar.

135 Austin, Bradford Hill, The Environment and DiseaseAssociation or Causation?, 58 PROC. ROYAL SOCY MED. 296, 299 (1965)Google Scholar.

136 Brief of Amici Curiae Kenneth Rothman et al. for Appellate, Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993) (No. 92-102).

137 Id.

138 Egilman et al., supra note 129, at 237.

139 See Stephen, E. Fienberg et al., Understanding and Evaluating Statistical Evidence in Litigation, 36 JURMETRICS J. 1, 21-23 (1995)Google Scholar.

140 Brief of Amici Curiae Kenneth Rothman et al. for Appellate, Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993) (No. 92-102) (quoting Kenneth Rothman, Significance Questing, 105 ANNALS INTERNAL MED. 445, 445-46 (1986)) (citations omitted). According to the Rothman et al. amicus brief:

A better approach to evaluating the error in scientific measurement is the use of confidence intervals. A confidence interval is a range of possible values for a parameter that is consistent with the observed data within specified limits. The process of calculating a confidence interval within the chosen limits is know as interval estimation.

An important advantage of interval estimation is that it: do[es] not require irrelevant null hypothesis to be set up nor [does it] force a decision about significance to be madethe estimates can be presented and evaluated by statistical and other criteria, by the researcher or the reader. In addition the estimates of one investigation can be compared with others. While it is often the case that different measurements or methods of investigation or theoretical approaches lead to different results, this is not a disadvantage; these differences reflect important theoretical differences about the meaning of the research and the conclusions to be drawn from it. And it is precisely those differences which are obscured by simply reporting the significance level of the results.

Id. (quoting L. Atkins & D. Jarrett, The Significance of Significance Tests, in DEMYSTIFYING SOCIAL STATISTICS (J. Irvine & I. Miles eds., 1979)).

141 A detailed example showing how results can be of public health significance but not statistical significance can be found in Ozonoff, supra note 104.

142 For example, a difference of one-eighth inch in height between East Coast children and West Coast children will be statistically significant if very large numbers of children on both coasts are measured.

143 See Colin, Tapper, Discovery in Modern Times: A Voyage Around the Common Law World, 67 CHI.-KENT L. REV. 217, 241 (1991)Google Scholar.

144 Id.

145 See Fienberg et al., supra note 139, at 14.

146 A good example is the Fisher Exact Test, commonly used for small tables frequently encountered in environmental epidemiology. Certain well known statistical programs even force the user to employ this test if several table cells contain expected values of less than five, even though it has been known for years that the test is inappropriate. Cf. Ralph, B. DAgostino et al., The Appropriateness of Some Common Procedures for Testing the Equality of Two Independent Binomial Populations, 42 AM. STATISTICIAN 198 (1988)Google Scholar.

147 MICHAEL OAKES, STATISTICAL INFERENCE: A COMMENTARY FOR THE SOCIAL AND BEHAVIOURAL SCIENCES vii-viii (1986). Oakes then goes on to quote a review by Dusoir of a statistics text in a technical journal:

A more fundamental criticism is that the book, as almost all other elementary statistics texts, presents statistics as if it were a body of coherent technical knowledge, like the principles of oscilloscope operation. In fact statistics is a collection of warring factions, with deep disagreements over fundamentals, and it seems dishonest not to point this out.

Id. at viii.

148 As expressed by the epidemiologist Kenneth Rothman in his Daubert amicus brief, The result of using significance testing as a criterion for decision making is that the focus is changed from the information presented by the observations themselves to conjecture about the role chance could have played in bringing about those observations. Brief of Amici Curiae Kenneth Rothman et al. for Appellate, Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993) (No. 92-102) (emphasis in original). Kenneth Rothman is the author of a standard text, KENNETH ROTHMAN & SANDER GREENLAND, MODERN EPIDEMIOLOGY (2d ed. 1997), and the former Editor-in-Chief of the journal EPIDEMIOLOGY.

149 See REFERENCE MANUAL ON SCIENTIFIC EVIDENCE 157 (2000) (causation is a judgment issue for epidemiologists and others interpreting the epidemiological data.); see also Kenneth Rothman & Sander Greenland, Causation and Causal Inference, in MODERN EPIDEMIOLOGY 7 (Kenneth Rothman & Sander Greenland eds., 2d ed. 1998). As professors Rothman and Greenland explain in their textbook:

Perhaps the most important common thread that emerges from the debated philosophies [of scientific causation] is Hume's legacy that proof is impossible in empiric science. This simple fact is especially important to epidemiologists, who often face the criticism that proof is impossible in epidemiology, with the implication that it is possible in other scientific disciplines. Such criticism may stem from a view that experiments are the definitive source of scientific knowledge. Such a view is mistaken . Even the most careful and detailed mechanistic dissection of individual events cannot provide more than associations .

Id. at 22.

150 See Daubert v. Merrell Dow Pharm., Inc., 43 F.3d 1311, 1320 (9th Cir. 1995). Judge Kosinski, in the Daubert remand, writes of the plaintiff's case that it does not attempt to show causation directly; instead, they rely on experts who present circumstantial proof of causation. Id. Of course there is no such thing as a direct proof of causation.

151 Professors Rothman and Greenland are not alone in their view that judgmentnot a checklistis a scientist's most useful tool in inferring causation. Indeed, that perspective is shared by a number of the nation's leading epidemiologists and other scientists, historians of science, and philosophers of science. Thus, an amicus brief tendered to the U.S. Supreme Court in the Daubert case by Harvard professors Stephen Jay Gould (Zoology, Geology, and History of Science, now deceased), Gerald Holton (Physics and History of Science), Everett Mendelsohn (History of Science), and Kathleen Joy Propert (Biostatistics), Columbia University professor Ronald Bayer (Sociomedical Sciences), and NYU professor Dorothy Nelkin (Sociology and Law) explained that [c]onclusiveness in inferring causalityin epidemiology as with the study of all free-living human beingsis a desire more often than an accomplishment. Brief of Amici Curiae Ronald Bayer et al. for Appellate, Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993) (No. 92-102) (quoting Mervyn Susser, Rules for Inference in Epidemiology, 6 REGULATORY TOXICOLOGY & PHARMACOLOGY 116, 127 (1986)). These scholars went on to observe that [a]s a consequence, those who seek in science the immutable truth they find lacking in the law are apt to be disappointed. Id. One notable similarity [between law and epidemiology] is the dependence of both fields upon subjective judgments . In the end, a quality which lawyers should understandjudiciousnessmatters more than any. Scientists use both deductive and inductive inference to sustain the momentum of a continuing process of research . The courts of law, and the courts of application, use inference to reach decisions about what action to take. Those decisions cannot rest on certitudes, most especially when population risks are converted into individual risks. Id. (quoting Susser, supra) (emphasis added).

152 EPA, supra note 115.

153 Id.

154 Of these, the most important are non-differential exposure misclassification and small sample size. See David Ozonoff, Assessing the Effects of Exposure Misclassification in Hazardous Waste Studies (1994) (paper presented at the annual meeting of the International Society of Environmental Epidemiology, Nov. 1994) (on file with author); see also David, Ozonoff et al., Health Problems Reported by Residents of a Neighborhood Contaminated by a Hazardous Waste Facility, 11 AM. J. INDUS. MED. 581 (1987)Google Scholar.

155 NATIONAL RESEARCH COUNCIL, ENVIRONMENTAL EPIDEMIOLOGY, VOLUME 2: USE OF THE GRAY LITERATURE AND OTHER DATA IN ENVIRONMENTAL EPIDEMIOLOGY 22 (1997).

156 Id.

157 DAUBERT: THE MOST INFLUENTIAL SUPREME COURT RULING YOUVE NEVER HEARD OF (June 2003), at http://defendingscience.org.

158 Id.

159 Id.

160 If 1,000 cases appear naturally and another 1,000 are due to exposure (the result of a RR = 2.0), then of every 2,000 cases only 1,000 or 50% would seem to be a result of the exposure.

161 See Fienberg et al., supra note 139.

162 Bailey et al., supra note 87.

163 Ralph Metzger, Epidemiology Can Be Your Friend: Using Epidemiology in the Courtroom, in ATLA ANNUAL CONVENTION REFERENCE MATERIALS, VOLUME 2, 2815 (2001).

164 See Sander, Greenland, Relation of Probability of Causation to Relative Risk and Doubling Dose: A Methodologic Error That Has Become a Social Problem, 89 AM. J. PUB. HEALTH 1166 (1999)Google Scholar; Sander, Greenland & James, M. Robins, Epidemiology, Justice and the Probability of Causation, 40 JURIMETRICS J. 321 (2000)Google Scholar.

165 For an illuminating comment, see Greenland, supra note 164. For a more extended discussion, see Greenland & Robins, supra note 164.

166 See, e.g., Marder v. G.D. Searle & Co., 630 F. Supp. 1087, 1092-93 (D. Md. 1986).

167 See Fienberg et al., supra note 139.

168 See DeLuca v. Merrell Dow Pharm., Inc., 922 F.2d 941 (3d Cir. 1990); State v. Sercey, 825 So.2d 959 (Fla. Dist. Ct. App. 2002).

169 See ERIC D. GREEN ET AL., PROBLEMS, CASES, AND MATERIALS ON EVIDENCE 753-943 (3d ed. 2000).

170 Id.

171 It should be noted here that high-dose animal studies are generally accepted by scientists and regulators. Cf. J. E., Huff et al., Carcinogenesis Studies: Results of 398 Experiments on 104 Chemicals from the U.S. National Toxicology Program, 534 ANNALS N.Y. ACAD. SCI. 1 (1988)Google Scholar.

172 External and internal validity are thus analogous to the reliability and fit criteria of the Daubert Court. See Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 590-91 (1993).

173 See Robert, R. Kuehn, Suppression of Environmental Science, 30 AM. J.L. & MED. 333 (2004)Google Scholar.

174 See infra Parts IV.A-B.

175 See, e.g., Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137 (1999); Gen. Elec. Co. v. Joiner, 522 U.S. 136 (1997); Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579 (1993); Anderson v. W.R. Grace & Co., 628 F. Supp. 1219 (D. Mass. 1986).

176 See, e.g., Jennifer, L. Bush, The Federal Lead Poisoning Prevention Program: Inadequate Guidance for an Expeditious Solution, 23 B.C. ENVTL. AFF. L. REV. 645 (1996)Google Scholar; Robert, A. Levy, The New Business of Government Sponsored Litigation, 9 KAN J. L. & PUB. POLY 592 (1994)Google Scholar; Jane, Schukoske, The Evolving Paradigm of Laws on Lead-Based Paint, 45 S.C. L. REV. 611 (1994)Google Scholar.

177 AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY, CAC, CASE STUDIES IN ENVIRONMENTAL MEDICINE: LEAD TOXICITY, at http://www.atsdr.cdc.gov/HEC/CSEM/lead/index.html (last updated Aug. 20, 2003); see also CDC PREVENTING LEAD POISONING, supra note 23 (link to Figures).

178 J.L., Annest et al., Chronological Trend in Blood Lead Levels Between 1976 and 1980, 308 NEW ENG. J. MED. 1373 (1983)Google Scholar.