Background This paper describes the methods and conceptual framework for Wave 1 of the Population Assessment of Tobacco and Health (PATH) Study data collection. The National Institutes of Health, through the National Institute on Drug Abuse, is partnering with the Food and Drug Administration’s (FDA) Center for Tobacco Products to conduct the PATH Study under a contract with Westat. Methods The PATH Study is a nationally representative, longitudinal cohort study of 45 971 adults and youth in the USA, aged 12 years and older. Wave 1 was conducted from 12 September 2013 to 15 December 2014 using Audio Computer-Assisted Self-Interviewing to collect information on tobacco-use patterns, risk perceptions and attitudes towards current and newly emerging tobacco products, tobacco initiation, cessation, relapse behaviours and health outcomes. The PATH Study’s design allows for the longitudinal assessment of patterns of use of a spectrum of tobacco products, including initiation, cessation, relapse and transitions between products, as well as factors associated with use patterns. Additionally, the PATH Study collects biospecimens from consenting adults aged 18 years and older and measures biomarkers of exposure and potential harm related to tobacco use. Conclusions The cumulative, population-based data generated over time by the PATH Study will contribute to the evidence base to inform FDA’s regulatory mission under the Family Smoking Prevention and Tobacco Control Act and efforts to reduce the Nation’s burden of tobacco-related death and disease.

We have conducted a longitudinal epidemiologic study among pregnant women from three cities in northern Chile: Taltal with 114 microg/L, Chañaral with 6 microg/L, and Antofagasta with 0.5 microg/L perchlorate in the public drinking water. We tested the hypothesis that long-term exposure to perchlorate at these levels may cause a situation analogous to iodine deficiency, thus causing increases in thyrotropin (TSH) and thyroglobulin (Tg) levels and decreased levels of free thyroxine (FT4), in either the mother during the early stages of gestation or the neonate at birth, or in the fetus cause growth retardation. We found no increases in Tg or TSH and no decreases in FT4 among either the women during early pregnancy (16.1 +/- 4.1 weeks), late pregnancy (32.4 +/- 3.0 weeks), or the neonates at birth related to perchlorate in drinking water. Neonatal birth weight, length, and head circumference were not different among the three cities and were consistent with current U.S. norms. Therefore, perchlorate in drinking water at 114 microg/L did not cause changes in neonatal thyroid function or fetal growth retardation. Median urinary iodine among the entire cohort was 269 microg/L, intermediate between that of pregnant women in the United States at National Health and Nutrition Examination Survey (NHANES) I and at NHANES III and consistent with current World Health Organization (WHO) recommendations. Median breast milk iodine was not decreased in the cities with detectable perchlorate. Analysis of maternal urinary perchlorate excretion indicates an additional dietary source of perchlorate.

The collapse of the World Trade Center (WTC) on 11 September 2001 exposed New York City firefighters to smoke and dust of unprecedented magnitude and duration. The chemicals and the concentrations produced from any fire are difficult to predict, but estimates of internal dose exposures can be assessed by the biological monitoring of blood and urine. We analyzed blood and urine specimens obtained from 321 firefighters responding to the WTC fires and collapse for 110 potentially fire-related chemicals. Controls consisted of 47 firefighters not present at the WTC. Sampling occurred 3 weeks after 11 September, while fires were still burning. When reference or background ranges were available, most chemical concentrations were found to be generally low and not outside these ranges. Compared with controls, the exposed firefighters showed significant differences in adjusted geometric means for six of the chemicals and significantly greater detection rates for an additional three. Arrival time was a significant predictor variable for four chemicals. Special Operations Command firefighters (n = 95), compared with other responding WTC firefighters (n = 226), had differences in concentrations or detection rate for 14 of the chemicals. Values for the Special Operations Command firefighters were also significantly different from the control group values for these same chemicals and for two additional chemicals. Generally, the chemical concentrations in the other firefighter group were not different from those of controls. Biomonitoring was used to characterize firefighter exposure at the WTC disaster. Although some of the chemicals analyzed showed statistically significant differences, these differences were generally small.