supporting statement B

Information Collection Request

Examining In-Vehicle Exposures to Air Pollutants and Corresponding
Health Outcomes of Commuters

Supporting Statement B

April 22, 2010

Fuyuen Yip, PhD, MPH

Team Lead, Air Pollution Team

Air Pollution and Respiratory Health Branch

EHHE/NCEH/CDC

4770 Buford Highway NE

MS F-58

Atlanta GA 30341

Phone: 770.488.3719

Fax: 770.488.1540

[email protected]

B. Collections of Information Employing Statistical Methods

B.1 Respondent Universe and Sampling Methods

The target population for this study includes who commute to work by automobile in the Atlanta metropolitan region.

In-vehicle air quality data will be collected using a variety of real-time and time-integrated (filter-based) techniques. Measured health outcomes include spirometry data (forced expiratory volume in one second, forced vital capacity), exhaled nitric oxide, exhaled breath condensate, heart rate and heart rate variability data, oximetry data, and measurements of blood cytokines and other inflammatory or pro-thrombotic biomarkers. We plan compare these endpoints to those measured at baseline as well as to conduct these measurements at set time-points following the exposures to create a time series. We also plan to compare changes between exposures conducted at different times of year.

Power calculations for selected a priori hypotheses of interest were conducted using Rochon’s non-central Wald χ² approximation for repeated measures experiments. PM_2.5 concentrations were randomly sampled (with 100 replicates) for 40 subjects from historical records of ambient PM2.5 concentrations at four monitoring stations in Atlanta during 1999 to 2003. PM_2.5-mediated health effect estimates and health measure variances were taken from Riediker et al. ²⁷. Estimates of within-subject correlations in health measurements are presented for both “moderate” and “weak” correlation scenarios, in order to determine their predicted effects on statistical power. The "moderate" correlation scenario assumes a correlation of 0.5 between health measurements taken on different days in the same subject and a correlation of 0.8 between health measurements taken a few hours apart on the same day in the same subject, after adjustment for pollutant exposures and other predictors. The "weak" correlation scenario is similar, but assumes a correlation of 0.2 for measurements on different days and 0.5 for measurements on the same day. Power estimates (with a sample size of 40) for most measurements under the “moderate” correlation scenario exceed 0.99 and exceed 0.96 for the “weak” correlation scenario.

B.2 Procedures for the Collection of Information

We have collected, and will continue to collect, health information using questionnaires, spirometry, exhaled breath tests, Holter monitoring (heart rate and heart rate variability) and collection of blood samples for analysis of cytokines and other biomarkers. We will conduct pulmonary function tests using spirometry instruments. The important measurements include forced vital capacity (FVC) or the greatest volume of air exhaled from a maximal inspiration to a complete exhalation; the forced expiratory volume in one second (FEV1) or the volume of air exhaled in the first second of a FVC maneuver; and the ratio between these two values: FEV1/FVC. During the test, it is critical that participants are properly coached to exert the maximum effort possible. The individuals who administer the spirometry tests were trained to conduct the test and properly coach study participants. Holter monitors will be attached to study subjects by personnel trained in their use in a gender-specific manner. Blood samples will be collected by trained phlebotomists.

Quality Control Procedures

The questionnaires are administered by trained interviewers. Data coding and preparation will be done by the principal investigator and staff at Emory University. Instrumentation will be evaluated for performance at the beginning and end of each exposure by experienced personnel. When appropriate, field blanks will be collected for the assessment of background levels of measured values.

B.3 Methods to Maximize Response Rates and Deal with Non-response

In the context of this study, “response rate” is defined as the percentage of subjects meeting our eligibility criteria who consent to participate and complete the study activities. As part of the consent process prior to enrollment, all subjects will be informed of the number of hours required to complete the study as well as the number and types of moderately-intrusive health measurements that will need to be performed. Recruits who decline to participate prior to enrollment will not be considered non-responsive. Only recruits who provide informed consent and undergo initial baseline characterization and subsequently withdraw before protocol completion will be considered non-responsive. In a previous exposure study involving a similar number of hours of subject participation, only 5% of subjects who began the protocol withdrew before completion. We expect a similar response rate for this study.

B.4 Test of Procedures or Methods to be Undertaken

All study materials have been evaluated in pilot tests involving nine or fewer respondents.

B.5 Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

CDC Investigators:

PI: Fuyuen Yip, PhD, MPH

Air Pollution Team Lead

Air Pollution Respiratory Health Branch/EHHE/NCEH/CDC

4770 Buford Highway NE, MS F58

Atlanta, GA 30341

Phone: 770.488.3719

[email protected]

Tegan Boehmer, PhD, MPH

Epidemiologist

Air Pollution Respiratory Health Branch/EHHE/NCEH/CDC

4770 Buford Highway NE, MS F58

Atlanta, GA 30341

Phone: 770.488.3714

[email protected]

Emory University Investigators:

PI: Jeremy Sarnat, Sc.D.

Assistant Professor

Department of Environmental and Occupational Health

Rollins School of Public Health

Emory University

1518 Clifton Road

Atlanta, GA 30322

Phone: 404-712-9725

[email protected]

Roby Greenwald, Ph.D.

Research Assistant Professor

Department of Environmental and Occupational Health

Rollins School of Public Health

Emory University

1518 Clifton Road

Atlanta, GA 30322

Phone: 404-727-4620

[email protected]

Cherry Wongtrakool, M.D.

Assistant Professor

Emory School of Medicine

Division of Pulmonary, Allergy and Critical Care

Whitehead Biomedical Research Building

615 Michael Street, Suite 205

Atlanta, GA 30322

Phone: 404-727-5283

[email protected]

References

1. B. Brunekreef, S.T. Holgate. Air pollution and health. 2002. Lancet, 360(9341), 1233-1242.

2. L. Curtis, W. Rea, P. Smith-Willis, E. Fenyves, Y. Pan. Adverse health effects of outdoor air pollutants. 2006. Environ. Int., 32(6), 815-830.

3. D.W. Dockery, C.A. Pope, X. Xu, J.D. Spengler, J.H. Ware, M.E. Fay, et al. An association between air pollution and mortality in six U.S. cities. 1993. N. Engl. J. Med., 329(24), 1753-1759.

4. A. Peters. Particulate matter and heart disease: evidence from epidemiological studies. 2005. Toxicol. Appl. Pharmacol., 207(2, S1), 477-482.

5. C.A. Pope, M.J. Thun, M.M. Namboodiri, D.W. Dockery, J.S. Evans, F.E. Speizer, et al. Particulate air pollution as a predictor of mortality in a prospective study of U.S. adults. 1995. Am. J. Respir. Crit. Care Med., 151(3), 669-674.

6. B. Brunekreef, N.A.H. Janssen, J. de Hartog, H. Harssema, M. Knape, P. van Vliet. Air pollution from truck traffic and lung function in children living near motorways. 1997. Epidemiology, 8(3), 298-303.

7. G. Hoek, B. Brunekreef, S. Goldbohm, P. Fischer, P.A. van den Brandt. Association between mortality and indicators of traffic-related air pollution in the Netherlands: a cohort study. 2002. Lancet, 360(9341), 1203-1209.

8. T. Lanki, J. Pekkanen, P. Aalto, R. Elosua, N. Berglind, D. D'Ippoliti, et al. Associations of traffic related air pollutants with hospitalisation for first acute myocardial infarction: the HEAPSS study. 2006. Occup. Environ. Med., 63(12), 844-851.

9. B. Oftedal, B. Brunekreef, W. Nystad, C. Madsen, S.-E. Walker, P. Nafstad. Residential outdoor air pollution and lung function in schoolchildren. 2008. Epidemiology, 19(1), 129-137.

10. A. Peters, S. von Klot, M. Heier, I. Trentinaglia, A. Hormann, H.E. Wichmann, et al. Exposure to traffic and the onset of myocardial infarction. 2004. N. Engl. J. Med., 351(17), 1721-1730.

11. J. Pekkanen, E.J. Brunner, H.R. Anderson, P. Tiittanen, R.W. Atkinson. Daily concentrations of air pollution and plasma fibrinogen in London. 2000. Occup. Environ. Med., 57(12), 818-822.

12. U. Gehring, J. Cyrys, G. Sedlmeir, B. Brunekreef, T. Bellander, P. Fischer, et al. Traffic-related air pollution and respiratory health during the first 2 years of life. 2002. Eur. Respir. J., 19(4), 690-698.

13. D.R. Gold, A.A. Litonjua, A. Zanobetti, B.A. Coull, J. Schwartz, G. MacCallum, et al. Air pollution and ST-segment depression in elderly subjects. 2005. Environ. Health Perspect., 113(7), 883-887.

14. J.S. Lwebuga-Mukasa, T. Oyana, A. Thenappan, S.J. Ayirookuzhi. Association between traffic volume and health care use for asthma among residents at a US-Canadian border crossing point. 2004. J. Asthma, 41(3), 289-304.

15. C.B. Pedersen, O. Raaschou-Nielsen, O. Hertel, P.B. Mortensen. New directions: air pollution from traffic and schizophrenia risk. 2004. Atmos. Environ., 38(22), 3733-3734.

16. C. Tonne, S. Melly, M. Mittleman, B. Coull, R. Goldberg, J. Schwartz. A case–control analysis of exposure to traffic and acute myocardial infarction. 2007. Environ. Health Perspect., 115(1), 53-57.

17. B. Urch, F. Silverman, P. Corey, J.R. Brook, K.Z. Lukic, S. Rajagopalan, et al. Acute blood pressure responses in healthy adults during controlled air pollution exposures. 2005. Environ. Health Perspect., 113(8), 1052-1055.

18. W.J. Gauderman, E. Avol, F. Gilliland, H. Vora, D. Thomas, K. Berhane, et al. The effect of air pollution on lung development from 10 to 18 years of age. 2004. N. Engl. J. Med., 351(11), 1057-1067.

19. C. Nordenhäll, J. Pourazar, M.-C. Ledin, J.-O. Levin, T. Sandström, E. Ädelroth. Diesel exhaust enhances airway responsiveness in asthmatic subjects. 2001. Eur. Respir. J., 17(5), 909-915.

20. R.J. Pandya, G. Solomon, A. Kinner, J.R. Balmes. Diesel exhaust and asthma: hypotheses and molecular mechanisms of action. 2002. Environ. Health Perspect., 110(S1), 103-112.

21. J. McCreanor, P. Cullinan, M.J. Nieuwenhuijsen, J. Stewart-Evans, E. Malliarou, L. Jarup, et al. Respiratory effects of exposure to diesel traffic in persons with asthma. 2007. N. Engl. J. Med., 357(23), 2348-2358.

22. H.S. Adams, M.J. Nieuwenhuijsen, R.N. Colvile, M.A.S. McMullen, P. Khandelwal. Fine particle (PM2.5) personal exposure levels in transport microenvironments, London, UK. 2001. Sci. Total Environ., 279(1-3), 29-44.

23. S.A. Fruin, A.M. Winer, C.E. Rodes. Black carbon concentrations in California vehicles and estimation of in-vehicle diesel exhaust particulate matter exposures. 2004. Atmos. Environ., 38(25), 4123-4133.

24. M. Riediker, R.W. Williams, R.B. Devlin, T.R. Griggs, P.A. Bromberg. Exposure to particulate matter, volatile organic compounds, and other air pollutants inside patrol cars. 2003. Environ. Sci. Technol., 37(10), 2084-2093.

25. C.E. Rodes, L. Sheldon, D. Whitaker, A. Clayton, K. Fitzgerald, J. Flanagan, et al. Measuring concentrations of selected air pollutants inside California vehicles. Sacramento: California ARB, 1998:178.

26. C. Sioutas, R.J. Delfino, M. Singh. Exposure assessment for atmospheric ultrafine particles (UFPs) and implications in epidemiologic research. 2005. Environ. Health Perspect., 113(8), 947-955.

27. S.A. Batterman, C.-Y. Peng, J. Braun. Levels and composition of volatile organic compounds on commuting routes in Detroit, Michigan. 2002. Atmos. Environ., 36(39-40), 6015-6030.

28. N.J. Lawryk, C.P. Weisel. Concentrations of volatile organic compounds in the passenger compartments of automobiles. 1996. Environ. Sci. Technol., 30(3), 810-816.

29. J.-W. Lee, W.-K. Jo. Actual commuter exposure to methyl-tertiary butyl ether, benzene and toluene while traveling in Korean urban areas. 2002. Sci. Total Environ., 291(1-3), 219-228.

30. W.-K. Jo, K.-H. Park. Commuter exposure to volatile organic compounds under different driving conditions. 1999. Atmos. Environ., 33(3), 409-417.

31. C.-C. Chan, H. Özkaynak, J.D. Spengler, L. Sheldon. Driver exposure to volatile organic compounds, CO, ozone, and NO₂ under different driving conditions. 1991. Environ. Sci. Technol., 25(5), 964-972.

32. A. Duci, A. Chaloulakou, N. Spyrellis. Exposure to carbon monoxide in the Athens urban area during commuting. 2003. Sci. Total Environ., 309(1-3), 47-58.

33. U.S. Census Bureau. Journey to work: 2000. Washington, DC: U.S. Department of Commerce, 2004:13.

34. U.S. Census Bureau. Average travel time to work: ranking table (county level). 2002.

35. Atlanta Regional Commission. Travel patterns in the Atlanta region. Atlanta: Atlanta Regional Commission, 2004:2.

Attachments

Attachment 1 Section 301 of the Public Health Service Act (42 USC 241)

Attachment 2 Federal Register Notice

Attachment 3 Pulmonary Health Questionnaire

Attachment 4 Symptom Diary

Attachment 5 Summary of In-Vehicle Data Collected During Scripted Commute

Attachment 6 Emory University IRB Approval