Evaluation of the causal framework used for setting National Ambient Air Quality Standards

Critical Reviews in Toxicology

Volumn 43, Issue 10, 2013, Pages 829-849

  Goodman, Julie E ^a   Prueitt, Robyn L ^a   Sax, Sonja N ^a   Bailey, Lisa A ^a   Rhomberg, Lorenz R ^a  

^a GRADIENT   (United States)

Author keywords

Air quality; Causal framework; Criteria pollutants; Risk assessment; Systematic review; Weight of evidence

Indexed keywords

OZONE;

AIR POLLUTANT; AIR POLLUTION; AIR QUALITY STANDARD; AMBIENT AIR; CAUSAL MODELING; CONCEPTUAL FRAMEWORK; ENVIRONMENTAL IMPACT ASSESSMENT; GOVERNMENT; MEASUREMENT ERROR; REVIEW; RISK ASSESSMENT; SCIENTIFIC LITERATURE; STANDARD; UNITED STATES;

AIR POLLUTION; OZONE; RESEARCH; RISK ASSESSMENT; UNITED STATES; UNITED STATES ENVIRONMENTAL PROTECTION AGENCY;

EID: 84888628894     PISSN: 10408444     EISSN: 15476898     Source Type: Journal    
DOI: 10.3109/10408444.2013.837864     Document Type: Review

References (80)

1. Abbey DE, Nishino N, McDonnell WF, et al. (1999). Long-term inhalable particles and other air pollutants related to mortality in nonsmokers. Am J Respir Crit Care Med, 159, 373-82. (Pubitemid 29084854)
2. Adami HO Berry SC, Breckenridge C, et al. (2011). Toxicology and epidemiology: Improving the science with a framework for combining toxicological and epidemiological evidence to establish causal inference. Toxicol Sci, 122, 223-34.
3. Adams WC. (2006). Comparison of chamber 6.6-h exposures to 0.04-0.08 ppm ozone via square-wave and triangular profiles on pulmonary responses. Inhal Toxicol, 18, 127-36. (Pubitemid 43062259)
4. Bachmann J. (2007). Will the circle be unbroken: a history of the US National Ambient Air Quality Standards. J Air Waste Manage Assoc, 57, 652-97. (Pubitemid 46982472)
5. Bell ML, Kim JY, Dominici F. (2007). Potential confounding of particulate matter on the short-term association between ozone and mortality in multisite time-series studies. Environ Health Perspect, 115, 1591-5.
6. Boffetta P, McLaughlin JK, La Vecchia C, et al. (2008). False-positive results in cancer epidemiology: a plea for epistemological modesty. J Natl Cancer Inst, 100, 988-95. (Pubitemid 352019795)
7. Borgert CJ, Mihaich EM, Ortego LS, et al. (2011). Hypothesis-driven weight of evidence framework for evaluating data within the US EPA's Endocrine Disruptor Screening Program. Regul Toxicol Pharmacol, 61, 185-91.
8. Brauer M, Blair J, Vedal S. (1996). Effect of ambient ozone exposure on lung function in farm workers. Am J Respir Crit Care Med, 154, 981-7.
9. Brown JS, Bateson TF, McDonnell WF. (2008). Effects of exposure to 0.06 ppm ozone on FEV1 in humans: a secondary analysis of existing data. Environ Health Perspect, 116, 1023-6.
10. Brown JS. [US EPA, National Center for Environmental Assessment (NCEA)]. (2007). Memo to Ozone NAAQS Review Docket (OAR-2005-0172) re: the effects of ozone on lung function at 0.06 ppm in healthy adults. 8p., June 14.
11. Chan CC, Wu TH. (2005). Effects of ambient ozone exposure on mail carriers' peak expiratory flow rates. Environ Health Perspect, 113, 735-8.
12. Clyde M. (2000). Model uncertainty and health effect studies for particulate matter. Environmetrics, 11, 745-63. (Pubitemid 32003729)
13. Dockery DW, Pope CA, Xu X, et al. (1993). An association between air pollution and mortality in six U.S. cities. N Engl J Med, 329, 1753-9. (Pubitemid 23355547)
14. European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC). (2009). Framework of the Integration of Human and Animal Data in Chemical Risk Assessment. ECETOC Technical Report No. 104. 130p., January.
15. Franklin M, Schwartz J. (2008). The impact of secondary particles on the association between ambient ozone and mortality. Environ Health Perspect, 116, 453-8. (Pubitemid 351864302)
16. Frey HC, Samet JM. (2011). Letter to L. Jackson re: CASAC Review of EPA's "Integrated Science Assessment for Lead (First External Review Draft-May 2011)". Clean Air Scientific Advisory Committee (CASAC). 120p., December 9. [Online] Available from: http://yosemite.epa.gov/sab/sabproduct.nsf/0/ D3E2E8488025344D85 2579610068A8A1/$File/EPA-CASAC-12-002-unsigned.pdf [last accessed 29 June 2012].
17. Gent JF, Triche EW, Holford TR, et al. (2003). Association of low-level ozone and fine particles with respiratory symptoms in children with asthma. JAMA, 290, 1859-67. (Pubitemid 37430602)
18. Girardot SP, Ryan PB, Smith SM, et al. (2006). Ozone and PM2.5 exposure and acute pulmonary health effects: a study of hikers in the Great Smoky Mountains National Park. Environ Health Perspect, 114, 1044-52. (Pubitemid 44018901)
19. Goodman JE, Dodge DG, Bailey LA. (2010). A framework for assessing causality and adverse effects in humans with a case study of sulfur dioxide. Regul Toxicol Pharmacol, 58, 308-22.
20. Goodman JE, Sax SN. (2012). Comments on the Integrated Science Assessment for Ozone and Related Photochemical Oxidants (Third External Review Draft). 125p. Submitted to EPA on 15 August 2012. Docket ID: EPA-HQ-ORD-2011-0050.
21. Health Effects Institute (HEI). 2003. Revised analyses of time-series studies of air pollution and health. 306p., May.
22. Higgins JPT, Green S. (2011). Cochrane handbook for systematic reviews of interventions (Version 5.1.0). The Cochrane Collaboration. March. Available from: http://www.cochrane-handbook.org/[last accessed 03 Feb 2012].
23. Hill AB. (1965). The environment and disease: association or causation? Proc R Soc Med, 58, 295-300.
24. Hoppe P, Praml G, Rabe G, et al. (1995). Environmental ozone field study on pulmonary and subjective responses of assumed risk groups. Environ Res, 71, 109-21. (Pubitemid 26425583)
25. Institute of Medicine (IOM). (2008). Improving the presumptive disability decision-making process for veterans. Committee on Evaluation of the Presumptive Disability Decision-Making Process for Veterans, Board on Military and Veterans Health, National Academies Press. 781p.
26. International Agency for Research on Cancer (IARC). (2006). Preamble to the IARC monographs on the evaluation of carcinogenic risks to humans. 27p. Available from: http://monographs.iarc.fr/ENG/Preamble/CurrentPreamble.pdf [last accessed 20 Sep 2012].
27. Ito K. (2003). Associations of particulate matter components with daily mortality and morbidity in Detroit, Michigan. In: Revised analyses of time-series studies of air pollution and health. Boston, MA: Health Effects Institute, 143-156.
28. Ito K, De Leon SF, Lippmann M. (2005). Associations between ozone and daily mortality: analysis and meta-analysis. Epidemiology, 16, 446-57. (Pubitemid 40847828)
29. Jerrett M, Burnett RT, Pope CA, et al. (2009). Long-term ozone exposure and mortality. N Engl J Med, 360, 1085-95.
30. Jerrett M, Burnett RT, Ma R, et al. (2005). Spatial analysis of air pollution and mortality in Los Angeles. Epidemiology, 16, 727-36. (Pubitemid 41681538)
31. Jurek AM, Greenland S, Maldonado G. (2008). How far from non-differential does exposure or disease misclassification have to be to bias measures of association away from the null? Int J Epidemiol, 37, 382-5. (Pubitemid 351494216)
32. Jurek AM, Greenland S, Maldonado G, Church TR. (2005). Proper interpretation of non-differential misclassification effects: expectations vs. observations. Int J Epidemiol, 34, 680-7. (Pubitemid 40852588)
33. Kamps AW, Roorda RJ, Brand PL. (2001). Peak flow diaries in childhood asthma are unreliable. Thorax, 56, 180-2.
34. Katsouyanni K, Samet JM, Anderson HR, et al. (2009). Air pollution and health: a European and North American Approach (APHENA). HEI Research Report 142. 132p., October 29.
35. Kim CS, Alexis NE, Rappold AG, et al. (2011). Lung function and inflammatory responses in healthy young adults exposed to 0.06 ppm ozone for 6.6 hours. Am J Respir Crit Care Med, 183, 1215-21.
36. Klimisch HJ, Andreae M, Tillmann U. (1997). A systematic approach for evaluating the quality of experimental toxicological and ecotoxico-logical data. Regul Toxicol Pharmacol, 25, 1-5. (Pubitemid 27117571)
37. Koop G, McKitrick R, Tole L. (2010). Air pollution, economic activity and respiratory illness: evidence from Canadian cities, 1974-1994. Environ Model Softw, 25, 873-85.
38. Koop G, Tole L. (2004). Measuring the health effects of air pollution: to what extent can we really say that people are dying from bad air? J Environ Econ Manage, 47, 30-54. (Pubitemid 38039036)
39. Korrick SA, Neas LM, Dockery DW, et al. (1998). Effects of ozone and other pollutants on the pulmonary function of adult hikers. Environ Health Perspect, 106, 93-9. (Pubitemid 28143863)
40. Lavelle KS, Schnatter AR, Travis KZ, et al. (2012). Framework for integrating human and animal data in chemical risk assessment. Regul Toxicol Pharmacol, 62, 302-12.
41. Lefohn AS, Hazucha MJ, Shadwick D, Adams WC. (2010). An alternative form and level of the human health ozone standard. Inhal Toxicol, 22, 999-1011.
42. Lipfert FW, Perry HM, Miller JP, et al. (2000). The Washington University-EPRI Veterans' Cohort Mortality Study: preliminary results. Inhal Toxicol, 12, 41-73.
43. Lipsett MJ, Ostro BD, Reynolds P, et al. (2011). Long-term exposure to air pollution and cardiorespiratory disease in the California teachers study cohort. Am J Respir Crit Care Med, 184, 828-35.
44. McClellan RO. (2012). Role of science and judgment in setting national ambient air quality standards: how low is low enough? Air Qual Atmos Health, 5, 243-58.
45. Miller KA, Siscovick DS, Sheppard L, et al. (2007). Long-term exposure to air pollution and incidence of cardiovascular events in women. N Engl J Med, 356, 447-58. (Pubitemid 46193072)
46. Moolgavkar SH, McClellan RO, Dewanji A, et al. (2013). Time-series analyses of air pollution and mortality in the United States: a subsampling approach. Environ Health Perspect, 121, 73-8.
47. Mortimer KM, Neas LM, Dockery DW, et al. (2002). The effect of air pollution on inner-city children with asthma. Eur Respir J, 19, 699-705. (Pubitemid 34285167)
48. Naeher LP, Holford TR, Beckett WS, et al. (1999). Healthy women's PEF variations with ambient summer concentrations of PM10, PM2.5, SO42-, H, and O3. Am J Respir Crit Care Med, 160, 117-25.
49. National Research Council (NRC). (2011). Review of the Environmental Protection Agency's Draft IRIS Assessment of Formaldehyde. National Academies Press. 194p., April. Available from: http://www.nap.edu/catalog/13142.html [last accessed 08 April 2011].
50. Neas LM, Dockery DW, Koutrakis P, Speizer, FE. (1999). Fine particles and peak flow in children: Acidity versus mass. Epidemiology, 10, 550-3. (Pubitemid 29398913)
51. Nicolich M. (2007). Letter Report to US EPA, Air and Radiation Docket. Re: Comments on EPA's Proposed "National Ambient Air Quality Standards for Ozone", 72 Fed Reg. 37, 818 (11 July 2007). Docket No. EPA-HQ-OAR-2005- 0172. October 9.
52. O'Connor GT, Neas L, Vaughn B, et al. (2008). Acute respiratory health effects of air pollution on children with asthma in US inner cities. J Allergy Clin Immunol, 121, 1133-9.
53. Rhomberg LR, Bailey LA, Goodman JE, et al. (2011a). Is exposure to formaldehyde in air causally associated with leukemia?-a hypothesis-based weight-of-evidence analysis. Crit Rev Toxicol, 41, 555-621.
54. Rhomberg LR, Bailey LA, Goodman JE. (2010). Hypothesis-based weight of evidence: a tool for evaluating and communicating uncertainties and inconsistencies in the large body of evidence in proposing a carcinogenic mode of action-naphthalene as an example. Crit Rev Toxicol, 40, 671-96.
55. Rhomberg LR, Chandalia JK, Long CM, Goodman JE. (2011b). Measurement error in environmental epidemiology and the shape of exposure-response curves. Crit Rev Toxicol, 41, 651-71.
56. Rhomberg LR, Goodman JE, Bailey LA, et al. (2013). A survey of frameworks for best practices in weight-of-evidence analyses. Crit Rev Toxicol. DOI: 10.3109/10408444.2013.832727.
57. Romieu I, Meneses F, Ramirez M, et al. (1998). Antioxidant supplementation and respiratory functions among workers exposed to high levels of ozone. Am J Respir Crit Care Med, 158, 226-32. (Pubitemid 28337185)
58. Sarnat JA, Brown KW, Schwartz J, et al. (2005). Ambient gas concentrations and personal particulate matter exposures: implications for studying the health effects of particles. Epidemiology, 16, 385-95. (Pubitemid 40586715)
59. Sarnat JA, Schwartz J, Catalano PJ, Suh HH. (2001). Gaseous pollutants in particulate matter epidemiology: confounders or surrogates? Environ Health Perspect, 109, 1053-61. (Pubitemid 33100412)
60. Schelegle ES, Morales CA, Walby WF, et al. (2009). 6.6-Hour inhalation of ozone concentrations from 60 to 87 parts per billion in healthy humans. Am J Respir Crit Care Med, 180, 265-72.
61. Smith RL, Xu B, Switzer P. (2009). Reassessing the relationship between ozone and short-term mortality in U.S. urban communities. Inhal Toxicol, 21, 37-61.
62. Spencer-Hwang R, Knutsen SF, Soret S, et al. (2011). Ambient air pollutants and risk of fatal coronary heart disease among kidney transplant recipients. Am J Kidney Dis, 58, 608-16.
63. Stieb DM, Szyszkowicz M, Rowe BH, Leech JA. (2009). Air pollution and emergency department visits for cardiac and respiratory conditions: A multi-city time-series analysis. Environ Health, 8, 25.
64. Stylianou M, Nicolich MJ. (2009). Cumulative effects and threshold levels in air pollution mortality: Data analysis of nine large US cities using the NMMAPS dataset. Environ Pollut, 157, 2216-23.
65. Swaen G, van Amelsvoort L. (2009). A weight of evidence approach to causal inference. J Clin Epidemiol, 62, 270-7.
66. Taubes G. (1995). Epidemiology faces its limits. Science, 269, 164-9.
67. US EPA. (2005). Guidelines for carcinogen risk assessment. Risk Assessment Forum, EPA/630/P-03/001F. March.
68. US EPA. (2006). Air quality criteria for ozone and related photochemical oxidants. Volume I. EPA 600/R-05/004aF. 821p., February.
69. US EPA. (2008a). Integrated science assessment for oxides of nitrogen. EPA/600/R-08/071. 260p., July.
70. US EPA. (2008b). Integrated science assessment for sulfur oxides-health criteria. EPA/600/R-08/047F. September.
71. US EPA. (2009). Integrated science assessment for particulate matter (final). EPA/600/R-08/139F. 2228p., December.
72. US EPA. (2010a). Integrated science assessment for carbon monoxide. EPA/600/R-09/019F. 593p., January.
73. US EPA. (2010b). Toxicological review of formaldehyde-inhalation assessment (CAS No. 50-00-0) in support of summary information on the integrated risk information system (IRIS). Volumes I-IV (Draft). EPA/635/R-10/002A. 1043p., June.
74. US EPA. (2012). Integrated science assessment for lead (third external review draft). EPA/600/R-10/075C. 1762p., November.
75. US EPA. (2013a). Integrated science assessment for ozone and related photochemical oxidants (final). EPA/600/R-10/076F. 1251p., February.
76. US EPA. (2013b). Process of reviewing the national ambient air quality standards. 2p., June. Available from: http://www.epa.gov/ttn/naaqs/review.html [last accessed 19 Aug 2013].
77. Wacholder S, Hartge P, Lubin JH, Dosemeci M. (1995). Non-differential misclassification and bias towards the null: a clarification [letter to the editor]. Occup Environ Med, 52, 557.
78. Xia Y, Tong H. (2006). Cumulative effects of air pollution on public health. Stat Med, 25, 3548-59. (Pubitemid 44575169)
79. Zanobetti A, Schwartz J. (2008). Is there adaptation in the ozone mortality relationship: a multi-city case-crossover analysis. Environ Health, 7, 22.
80. Zanobetti A, Schwartz J. (2011). Ozone and survival in four cohorts with potentially predisposing diseases. Am J Respir Crit Care Med, 184, 836-41.