Environmental health science for regulatory decisionmaking

Duke Environmental Law and Policy Forum

Volumn 21, Issue 2, 2011, Pages 259-293

  Birnbaum, Linda S ^a   Jung, Paul ^a   Newton, Sheila A ^a  

^a NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DECISION MAKING; ENVIRONMENTAL EFFECT; HEALTH IMPACT;

EID: 84856996921     PISSN: 10643958     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (186)

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40. Examples include lead, estrogens, and bisphenol A. See Bruce B. Lanphear et al., Low-Level Environmental Lead Exposure and Children's Intellectual Function: An International Pooled Analysis, 113 EVNTL. HEALTH PERSP. 894 (2005) (lead)
41. Catherine A. Richter et al., In Vivo Effects of Bisphenol A in Laboratory Rodent Studies. 24 REPROD. TOXICOLOGY 199 (2007) (bisphenol A)
42. D.M. Sheehan et al., No Threshold Dose for Estradiol-Induced Sex Reversal of Turtle Embryos: How Little Is Too Much?, 107 ENVTL. HEALTH PERSP. 155 (1999) (estrogen).
43. See Dana C. Dolinoy et al., Epigenetic Gene Regulation: Linking Early Developmental Environment to Adult Disease, 23 REPROD. TOXICOLOGY 297 (2007)
44. Walter J. Rogan & N. Beth Ragan, Evidence of Effects of Environmental Chemicals on the Endocrine System in Children, 112 PEDIATRICS 247 (2003).
45. Retha R. Newbold et al., Adverse Effects of the Model Environmental Estrogen Diethylstilbestrol are Transmitted to Subsequent Generations, 147 ENDOCRINOLOGY S11 (2006).
46. Sickle cell anemia and Huntington's disease are two examples of disease resulting from genetic mutations. More information about these diseases are available at NINDS Huntington's Disease Information Page, NAT'L INST. OF NEUROLOGICAL DISORDERS & STROKE, http://www.ninds.nih.gov/disorders/huntington/huntington.htm (last updated Aug. 13, 2010)
47. Sickle Cell Anemia, NAT'L HEART LUNG & BLOOD INST. http://www.nhlbi.nih.gov/health/dci/Diseases/Sca/SCA_WhatIs.html (last revised Feb. 2011).
48. See, e.g., Eliezer Bermúdez et al., Environmental Tobacco Smoke Is Just as Damaging to DNA as Mainstream Smoke, 102 ENVTL. HEALTH PERSP. 870, 873-74 (1994)
49. Frederica Perera et al., In Utero DNA Damage from Environmental Pollution is Associated with Somatic Gene Mutation in Newborns, 11 CANCER EPIDEMIOLOGY, BIOMARKERS & PREVENTION 1134, 1136 (2002).
50. See, e.g., Bruce K. Rubin, Exposure of Children with Cystic Fibrosis to Environmental Tobacco Smoke, 323 NEW ENG. J. MED. 782, 782 (1990)
51. Michael S. Schechter, Non-Genetic Influences on Cystic Fibrosis Lung Disease: The Role of Sociodemographic Characteristics, Environmental Exposures, and Healthcare Interventions, 26 PEDIATRIC PULMONOLOGY S82 (2004).
52. M. Neri et al., Genetic Susceptibility to Malignant Pleural Mesothelioma and Other Asbestos-Associated Diseases, 659 MUTATION RES. 126, 134 (2008).
53. Juan Alguacil et al., Risk of Pancreatic Cancer and Occupational Exposures in Spain, 44 ANNALS OCCUPATIONAL HYGIENE 391, 400 (2000) (pancreatic cancer)
54. Yvonne Marie Coyle, The Effect of Environment on Breast Cancer Risk, 84 BREAST CANCER RES. & TREATMENT 273, 273-75, 282 (2004) (breast cancer)
55. Jose M. Ramon et al., Dietary Factors and Gastric Cancer Risk: A Case-Control Study in Spain, 71 CANCER 1731, 1731 (1993) (gastric cancer).
56. James J. Nora, Multifactorial Inheritance Hypothesis for the Etiology of Congenital Heart Diseases: The Genetic-Environmental Interaction, 38 CIRCULATION 604, 604 (1968) (cardiac malformations)
57. Joanna S. Zeiger et al., Oral Clefts, Maternal Smoking, and TGFA: A Meta-Analysis of Gene-Environmental Interaction, 42 CLEFT PALATE-CRANIOFACIAL J. 58, 58 (2005) (cleft palate).
58. Frank Michal et al., Impact of the Environment on Reproductive Health: Executive Summary, 101 ENVTL. HEALTH PERSP. (SUPP.) 159, 159 (1993).
59. Stephen I. Rennard, COPD: Overview of Definitions, Epidemiology, and Factors Influencing Its Development, 113 CHEST 235S (1998)
60. Victor L. Roggli, Human Disease Consequences of Fiber Exposures: A Review of Human Lung Pathology and Fiber Burden Data, 88 ENVTL. HEALTH PERSP. 295 (1990)
61. Padmaja Subbarao et al., Asthma: Epidemiology, Etiology and Risk Factors, 181 CAN. MED. ASS'N J. E181, E181 (2009).
62. Donato A. Di Monte, Mitra Lavasani & Amy B. Manning-Bog, Environmental Factors in Parkinson's Disease, 23 NEUROTOXICOLOGY 487, 487 (2002).
63. Eric London & Ruth A. Etzel, The Environment as an Etiologic Factor in Autism: A New Direction for Research, 108 ENVTL. HEALTH PERSP. 401, 401 (2000).
64. Alan P. Wolffe & Marjori A. Matzke, Epigenetics: Regulation Through Repression, 286 SCIENCE 481, 481 (1999) ("Epigenetics is the study of heritable changes in gene expression that occur without a change in DNA sequence.").
65. Sherry G. Selevan et al., Identifying Critical Windows of Exposure for Children's Health, 108 ENVTL. HEALTH PERSP. 451, 451 (2000) ("The same exposure at different times would create a different spectrum of, in this case, malformations due to the timing of the development of different organ systems.").
66. Rob Stein, Theory Says Disease Tendencies Begin in Womb, WASH. POST, July 7, 2003, at A4.
67. Frederick S. vom Saal & John Peterson Myers, Bisphenol A and Risk of Metabolic Disorders, 300 J. AM. MED. ASS'N 1353, 1354 (2008) ("Despite decades of published observations by endocrinologists reporting nonmonotonic dose-response curves for hormonally active compounds, the core assumption used by the FDA, the Environmental Protection Agency, and the European Food Safety Authority in estimating ADIs for environmental chemicals is still based on a concept first articulated in the 16th century: 'The dose makes the poison'; i.e., dose response curves are assumed to be monotonic for environmental chemicals.").
68. Douglas A. Bell et al., Genetic Risk and Carcinogen Exposure: A Common Inherited Defect of the Carcinogen-Metabolism Gene Glutathione S-Transferase M1 (GSTM1) That Increases Susceptibility to Bladder Cancer, 85 J. NAT'L CANCER INST. 1159, 1159 (1993).
69. See, e.g., OFFICE OF PESTICIDE PROGRAMS, U.S. ENVTL. PROT. AGENCY, DOCKET NO. OPP-00757, DETERMINATION OF THE APPROPRIATE FQPA FACTOR(S) IN TOLERANCE ASSESSMENT (Feb. 29, 2002), available at http://www.epa.gov/pesticides/trac/science/determ.pdf
70. Peter M. Chapman et al., A Critical Evaluation of Safety (Uncertainty) Factors for Ecological Risk Assessment, 17 ENVTL. TOXICOLOGY & CHEMISTRY 99, 99 (1998).
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72. Theo Vermeire et al., Assessment Factors for Human Health Risk Assessment: A Discussion Paper, 29 CRITICAL REVS. TOXICOLOGY 459 (1999).
73. See John W. Hollingsworth et al., Ozone Activates Pulmonary Dendritic Cells and Promotes Allergic Sensitization Through a Toll-Like Receptor 4-Dependent Mechanism, 125 J. ALLERGY & CLINICAL IMMUNOLOGY 1167, 1170 (2010).
74. Joshua F. Robinson et al., Integrating Genetic and Toxicogenomic Information for Determining Underlying Susceptibility to Developmental Disorders, 88 BIRTH DEFECTS RES. A: CLINICAL & MOLECULAR TERATOLOGY 920, 929 (2010).
75. Wolffe & Matzke, supra note 54, at 481.
76. Id. at 481-83
77. M. Fabbri & G.A. Calin, Epigenetics and miRNAs in Human Cancer, 70 ADVANCES IN GENETICS 87 (2010)
78. Peter A. Jones & Daiya Takai, The Role of DNA Methylation in Mammalian Epigenetics, 293 SCIENCE 1068 (2001).
79. P. D. Gluckman et al., Effect of In Utero and Early-Life Conditions on Adult Health and Disease, 359 NEW ENG. J. MED. 61 (2008).
80. H. M. Abdolmaleky et al., Genetics and Epigenetics in Major Psychiatric Disorders: Dilemmas, Achievements, Applications, and Future Scope 5 AM. J. PHARMACOGENOMICS 149 (2005)
81. S. Akbarian, Epigenetics of Schizophrenia, 4 CURRENT TOPICS BEHAVIORAL NEUROSCIENCE 611 (2010)
82. David J.P. Barker et al., Growth and Living Conditions in Childhood and Hypertension in Adult Life: A Longitudinal Study 20 J. HYPERTENSION 1951 (2002) (attributing the correlation between low birthweight and hypertension to reduced number of nephrons, as determined in utero)
83. David J.P. Barker & Phillipa M. Clark, Fetal Undernutrition and Disease in Later Life, 2 REV. REPROD. 105 (1997) (cancer)
84. Johan Eriksson et al., Fetal and Childhood Growth and Hypertension in Adult Life, 36 J. HYPERTENSION 790 (2000) (cardiovascular disease)
85. T.J. Roseboom et al., Coronary Heart Disease After Prenatal Exposure to the Dutch Famine, 1944-45, 84 HEART 595 (2000) (cardiovascular disease)
86. R.P. Sharma, Schizophrenia, Epigenetics and Ligand-Activated Nuclear Receptors: A Framework for Chromatin Therapeutics 72 SCHIZOPHRENIA RES. 79 (2005).
87. Autumn J. Bernal & Randy L. Jirtle, Epigenomic Disruption: The Effects of Early Developmental Exposures, 88 BIRTH DEFECTS RES. A: CLINICAL & MOLECULAR TERATOLOGY 938, 938-43 (2010).
88. Sayyed K. Zaidi et al., Bookmarking the Genome: Maintenance of Epigenetic Information, 286 J. BIOLOGICAL CHEMISTRY 18,355 (2011).
89. Peter W. Laird, The Power and the Promise of DNA Methylation Markers, 3 NATURE REVS. CANCER 253, 262 (2003) ("The development of DNA methylation markers that are predictive of a response to chemotherapy is still in its infancy. Several studies have reported associations between DNA methylation markers and response to chemotherapy. Others have expressed reservations regarding the conclusions that can be drawn from such retrospective multidrug studies.").
90. Henk J. Blom et al., Neural Tube Defects and Folate: Case Far from Closed, 7 NATURE REVS. NEUROSCIENCE 724, 724 (2006) ("It has been known for more than 20 years that women can reduce their risk of having an NTD-affected pregnancy by taking folic acid supplements. However, the underlying mechanisms by which folic acid contributes to a reduction in the risk of an infant being born with an NTD or other types of malformation are unclear. Biochemical, genetic and epidemiological observations have led to the development of the methylation hypothesis, which suggests that folic acid prevents neural tube defects by stimulating cellular methylation reactions.")
91. Cf. Lanphear et al., supra note 41, at 898 ("We found evidence of lead-related intellectual deficits among children who had maximal blood lead levels < 7.5 μg/dL. Indeed, e found no evidence of a threshold. Nevertheless. we cannot entirely resolve the question of whether children are more vulnerable to lead exposure during the first 2 years of life.").
92. See, e.g., P. Grandjean & P.J. Landrigan, Developmental Neurotoxicity of Industrial Chemicals, 368 LANCET 2167, 2171-74 (2006) (PCBs, lead, mercury, etc.)
93. Todd A. Jusko et al., Blood Lead Concentrations < 10 microg/dL and Child Intelligence at 6 Years of Age, 116 ENVTL. HEALTH PERSP. 243, 243 (2008) (lead)
94. Gary J. Myers et al., Postnatal Exposure to Methyl Mercury from Fish Consumption: A Review and New Data from the Seychelles Child Development Study, 30 NEUROTOXICOLOGY 338, 338 (2009) (mercury).
95. Susan L. Schantz & John. J. Widholm, Cognitive Effects of Endocrine-Disrupting Chemicals in Animals, 109 ENVTL. HEALTH PERSP. 1197, 1197 (2001).
96. Jerrold J. Heindel, Editorial, Role of Exposure to Environmental chemicals in the Developmental Basis of Disease and Dysfunction, 23 REPROD. TOXICOLOGY 257, 257 (2007).
97. Id. at 258.
98. Id. at 257-58.
99. NICEATM-ICCVAM Home, supra note 23.
100. See generally BISPHENOL A MONOGRAPH, supra note 21.
101. See Lanphear et al., supra note 41, at 899 ("Still, in studies that did examine other relevant covariates, such as breast-feeding and iron status, the estimated effect of lead was not altered appreciably.").
102. Bernal and Jirtle, supra note 65, at 938-43.
103. Background Information, BREAST CANCER & THE ENV'T RESEARCH PROGRAM, http://www.bcerc.org/about.htm (last visited Apr. 19, 2011).
104. Julie B. Herbstman et al., Prenatal Exposure to PBDEs and Neurodevelopment, 118 ENVTL. HEALTH PERSP. 712, 712 (2010).
105. Cf. id.; Key Findings & Interventions, COLUMBIA CTR. FOR CHILDREN'S ENVTL. HEALTH, http://www.cumc.columbia.edu/dept/mailman/ccceh/findings.html (last visited Aug. 10, 2011).
106. Matthew D. Anway & Michael K. Skinner, Epigenetic Transgenerational Actions of Endocrine Disruptors, 147 ENDOCRINOLOGY (SUPP.) S43, S45-46 (2006).
107. Retha R. Newbold, Elizabeth Padilla-Banks & Wendy N. Jefferson, Environmental Estrogens and Obesity, 304 MOLECULAR & CELLULAR ENDOCRINOLOGY 84, 85 (2009).
108. Felix Grun & Bruce Blumberg, Environmental Obsogens: Organotins and Endocrine Disruption via Nuclear Receptor Signaling, 147 ENDOCRINOLOGY S50, S50 (2006).
109. Dana C. Dolinoy, Jennifer R. Wedman & Randy L. Jirtle, Epigenetic Gene Regulation: Linking Early Developmental Environment to Adult Disease, 23 REPROD. TOXICOLOGY 297, 298 (2007).
110. See C.G. Bornehag & E. Nanberg, Phthalate Exposure and Asthma in Children, 33 INT'L J. ANDROLOGY 333, 333 (2010)
111. Rodney R. Dietert & Judith T. Zelikoff, Early-life Environment, Developmental Immunotoxicology, and the Risk of Pediatric Allergic Disease Including Asthma, 83 BIRTH DEFECTS RES. PART B: DEVELOPMENTAL & REPROD. TOXICOLOGY 547, 547 (2008).
112. Cristina Casals-Casas & Beatrice Desvergne, Endocrine Disruptors: From Endocrine to Metabolic Disruption, 73 ANN. REV. PHYSIOLOLOGY 135, 135 (2011).
113. Bernard Weiss, Endocrine Disruptors as a Threat to Neurological Function, 305 J. NEUROLOGICAL SCI. 11 (2011).
114. Amir Miodovnik et al., Endocrine Disruptors and Childhood Social Impairment, 32 NEUROTOXICOLOGY. 261 (2011).
115. Newbold, Padilla-Banks & Jefferson, supra note 88, at 84.
116. Evanthia Diamanti-Kandarakis et al., Endocrine-Disrupting Chemicals: An Endocrine Society Scientific Statement, 30 ENDOCRINE REVS. 293 (2009).
117. Susan Y. Euling et al., Examination of US Puberty-Timing Data from 1940 to 1994 for Secular Trends: Panel Findings, 121 PEDIATRICS S172 (2008).
118. Estimates of Funding for Various Research Condition, and Disease Categories, NAT'L INSTS. OF HEALTH RESEARCH PORTFOLIO ONLINE REPORTING TOOLS (Feb. 14, 2011), http://report.nih.gov/rcdc/categories/.
119. See also Project Listing by Category, NAT'L INSTS. OF HEALTH RESEARCH PORTFOLIO ONLINE REPORTING TOOLS (Feb. 14, 2011), http://report.nih.gov/rcdc/categories/ProjectSearch.aspx?FY=2010&ARRA=N&DCat=Obesity.
120. See Michele La Merrill & Linda S. Birnbaum, Childhood Obesity and Environmental Chemicals, 78 MOUNT SINAI J. MED. 22 (2011).
121. Schantz and Widholm, supra note 71, at 1197.
122. Grandjean and Landrigan, supra note 70, at 1-9.
123. Since You Asked-Bisphenol A, NAT'L INST. OF ENVTL. HEALTH SCI., http://www.niehs.nih.gov/news/sya/sya-bpa/ (lats reviewed Sept. 8, 2011).
124. Paul J. Lioy, Exposure Science: A View of the Past and Milestones for the Future, 118 ENVTL. HEALTH PERSP. 1081, 1081 (2010).
125. Id. at 1083.
126. Genes, Environment and Health Initiative, NAT'L INSTS. OF HEALTH, http://www.gei.nih.gov/ (last updated Feb. 4, 2010).
127. See, e.g., Eddy Ball, Air-Sampling Robot on Florida Beach, ENVTL. FACTOR, Oct. 2007, http://www.niehs.nih.gov/news/newsletter/2007/october/robot.cfm.
128. see also Sensor Technologies for Environmental Exposure Assessment, GENES, ENV'T & HEALTH INITIATIVE, http://www.gei.nih.gov/exposurebiology/program/sensor.asp (last updated Oct. 6, 2008).
129. See Validation and Field Testing of New Tools for Characterizing the Personal Environment, NAT'L INSTS. OF HEALTH, http://grants.nih.gov/grants/guide/rfa-files/RFA-ES-10-007.html (last visited Apr. 22, 2011).
130. Dioxins, NAT'L INST. OF ENVTL. HEALTH SCI., http://www.niehs.nih.gov/health/topics/agents/dioxins/index.cfm (last updated Feb. 7, 2011).
131. Known and Probable Human Carcinogens, AM. CANCER SOC'Y, http://www.cancer.org/Cancer/CancerCauses/OtherCarcinogens/GeneralInformationaboutCarcinogens/known-and-probable-human-carcinogens (last updated Feb. 17, 2011).
132. See Dioxin Toxicity Equivalency Factors for Human Health, OFFICE OF THE SCI.ADVISOR, U.S. ENVTL. PROT. AGENCY, http://www.epa.gov/raf/hhtefguidance/ (last updated Mar. 1, 2011).
133. OFFICE OF THE SCI. ADVISOR, U.S. ENVTL. PROT. AGENCY, EPA/600/R-10/005 RECOMMENDED TOXICITY EQUIVALENCE FACTORS (TEFS) FOR HUMAN HEALTH RISK ASSESSMENTS OF 2,3,7,8-TETRACHLORODIBENZO-P-DIOXIN AND DIOXIN-LIKE COMPOUNDS 2 (2010), available at http://www.epa.gov/osa/raf/files/tefs-for-dioxin-epa-00-r-10-005-final.pdf.
134. See NAT'L TOXICOLOGY PROGRAM, DEP'T OF HEALTH AND HUMAN SERVICES, NTP TR 526, NIH PUB. NO. 06-4462, NTP TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF A MIXTURE OF 2,3,7,8-TETRACHLORODIBENZO-P-DIOXIN (TCDD) (CAS NO. 1746-01-6), 2,3,4,7,8-PENTACHLORODIBENZOFURAN (PECDF) (CAS NO. 57117-31-4), AND 3,3',4,4',5-PENTACHLOROBIPHENYL (PCB 126) (CAS NO. 57465-28-8) IN FEMALE HARLAN SPRAGUE-DAWLEY RATS (GAVAGE STUDIES) (2006), available at http://ntp.niehs.nih.gov/files/526_Web_Final.pdf.
135. See Martin Van den Berg et al., The 2005 World Health Organization Reevaluation of Human and Mammalian Toxic Equivalency Factors for Dioxins and Dioxin-Like Compounds, 93 TOXICOLOGICAL SCI., 223, 225-26.
136. See Organophosphate Pesticides: Revised Cumulative Risk Assessment, U.S. ENVTL. PROT. AGENCY, http://www.epa.gov/pesticides/cumulative/rra-op/ (last updated Apr. 22, 2011).
137. Michael H. Surgan, Toxicity Tests: "Inert" and Active Ingredients, 113 ENVTL. HEALTH PERSP. A657-58, A658 (2005) ("[F]or many pesticide products, little or no information about the identity of inert ingredients is publicly available. [T]he identity of inert ingredients is rarely revealed in the open literature, publicly available regulatory documents, or product labels.").
138. See also, e.g., 21 C.F.R. § 701.3(a) (2011) ("The label on each package of a cosmetic shall bear a declaration of the name of each ingredient in descending order of predominance").
139. See also generally R.E. Baynes & J.E. Riviere, Influence of Inert Ingredients in Pesticide Formulations on Dermal Absorption of Carbaryl, 59 AM. J. VETERINARY RES. 168 (1998) (pesticides)
140. K. Noiles & R. Vender, Are Excipients Really Inert Ingredients? A Review of Adverse Reactions to Excipients in Oral Dermatologic Medications in Canada, 14 J. CUTANEOUS MED. & SURGERY 105 (2010) (pesticides)
141. Cosmetic Labeling Manual, U.S. FOOD & DRUG ADMIN., http://www.fda.gov/Cosmetics/CosmeticLabelingLabelClaims/CosmeticLabelingManual/default.htm (last updated May 13, 2009) (cosmetics).
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143. Gilles-Eric Seralini,"Inert" and Active Ingredients: Seralini Responds, 113 ENVTL. HEALTH PERSP. A658, A658 (2005)
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