THE TREND TOWARDS IMPLEMENTING THE PRECAUTIONARY PRINCIPLE IN US REGULATION OF NANOMATERIALS

The precautionary principle provides a framework for regulating emerging technologies in general and nanomaterials in particular. It counsels action in the presence of uncertainties about risk instead of assuming that nanomaterials are safe unless proven hazardous. Nanomaterials are regulated under different statutory programs depending on whether they are drugs, pesticides or other commercial chemicals. Recent developments in the regulation of nanomaterials that are not drugs or pesticides have demonstrated a trend towards application of the precautionary principle. This is a paradigm shift away from the requirement built into past interpretations of the Toxic Substances Control Act (“TSCA”) that manufacturing, processing and use of chemical substances cannot be restricted unless the regulatory authority proves an unreasonable risk. This same paradigm shift is incorporated into recent legislative proposals to amend TSCA

Cancer Incidence among Former Love Canal Residents

Ba c k g r o u n d: The Love Canal was a rectangular 16-acre, 10-ft-deep chemical waste landfill situated in a residential neighborhood in Niagara Falls, New York. This seriously contaminated site came to public attention in 1978. Only one prior study examined cancer incidence in former residents of the Love Canal neighborhood (LC). Objective: In this study we aimed to describe cancer incidence in former LC residents from 1979 to 1996 and to investigate whether it differs from that of New York State (NYS) and Niagara County (NC). Me t h o d s: From 1978 to 1982, we interviewed 6,181 former residents, and 5,052 were eligible to be included in this study. In 1996, we identified 304 cancer diagnoses in this cohort using the NYS Cancer Registry. We compared LC cancer incidence with that of NYS and NC using standardized incidence ratios (SIRs), and we compared risks within the LC group by potential exposure to the landfill using survival analysis. Res u l t s: SIRs were elevated for cancers of the bladder [SIR NYS = 1.44; 95 % confidence interval (CI), 0.91–2.16] and kidney (SIR NYS = 1.48; 95 % CI, 0.76–2.58). Although CIs included 1.00, other studies have linked these cancers to chemicals similar to those found at Love Canal. We also found higher rates of bladder cancer among residents exposed as children, based on two cases. Co n c l u s i o n s: In explaining these excess risks, the role of exposure to the landfill is unclear given such limitations as a relatively small and incomplete study cohort, imprecise exposure measurements, and the exclusion of cancers diagnosed before 1979. Given the relatively young age of the cohort, further surveillance is warranted. Key w o r d s: cancer, community health, exposure assessment, hazardous waste sites, Love Canal. Environ Health Perspect 117:1265–1271 (2009). doi:10.1289/ehp.0800153 available vi

State-of-the-Science Workshop Report: Issues and Approaches in Low-Dose–Response Extrapolation for Environmental Health Risk Assessment

Low-dose extrapolation model selection for evaluating the health effects of environmental pollutants is a key component of the risk assessment process. At a workshop held in Baltimore, Maryland, on 23–24 April 2007, sponsored by U.S. Environmental Protection Agency and Johns Hopkins Risk Sciences and Public Policy Institute, a multidisciplinary group of experts reviewed the state of the science regarding low-dose extrapolation modeling and its application in environmental health risk assessments. Participants identified discussion topics based on a literature review, which included examples for which human responses to ambient exposures have been extensively characterized for cancer and/or noncancer outcomes. Topics included the need for formalized approaches and criteria to assess the evidence for mode of action (MOA), the use of human versus animal data, the use of MOA information in biologically based models, and the implications of interindividual variability, background disease processes, and background exposures in threshold versus nonthreshold model choice. Participants recommended approaches that differ from current practice for extrapolating high-dose animal data to low-dose human exposures, including categorical approaches for integrating information on MOA, statistical approaches such as model averaging, and inference-based models that explicitly consider uncertainty and interindividual variability

Children's exposure to second hand smoke at home : a cross-sectional study in Portugal

Second-hand tobacco smoke (SHS) is a major indoor pollutant that causes serious health problems for all exposed, especially children. Children are often exposed to SHS at home, due to parental or other households’ or guests’ smoking. This study describes Portuguese children's exposure to SHS at home (total and by Portuguese main regions). In 2010/2011, a questionnaire was applied to a sample of Portuguese children in the 4th grade (N = 3187, mean age 9.05 ± 0.7 years, 51.1% male). Descriptive analysis, chi-square tests and crude odds ratios were performed. Of the participants, 62.9% of those with smoking parents and 19.2% of those with non-smoking parents were exposed to SHS at their home. Parental smoking varied significantly among regions and was significantly associated with children's exposure to SHS at home. Children's exposure to SHS at home was high, especially if their parents smoke. Children living in Lisbon Region presented the highest SHS exposure rate. The association of SHS exposure with geographic regions suggests the influence of social and contextual factors on smoking behaviour and on tobacco control effectiveness. Our findings highlight the need to effectively prevent children's SHS exposure at their home and to develop tailored tobacco control measures by region.This work was supported by FEDER through the Programa Operacional Factores de Competitividade - COMPETE (FCOMP-01-0124-FEDER-009117), and by FCT - Fundacao para a Ciencia e a Tecnologia (Ref. PTDC/CPE-CED/098281/2008)

Suicide risk in long‐term care facilities: a systematic review

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/109565/1/gps4142.pd

Scientific and Legal Perspectives on Science Generated for Regulatory Activities

This article originated from a conference that asked “Should scientific work conducted for purposes of advocacy before regulatory agencies or courts be judged by the same standards as science conducted for other purposes?” In the article, which focuses on the regulatory advocacy context, we argue that it can be and should be. First, we describe a set of standards and practices currently being used to judge the quality of scientific research and testing and explain how these standards and practices assist in judging the quality of research and testing regardless of why the work was conducted. These standards and practices include the federal Information Quality Act, federal Good Laboratory Practice standards, peer review, disclosure of funding sources, and transparency in research policies. The more that scientific information meets these standards and practices, the more likely it is to be of high quality, reliable, reproducible, and credible. We then explore legal issues that may be implicated in any effort to create special rules for science conducted specifically for a regulatory proceeding. Federal administrative law does not provide a basis for treating information in a given proceeding differently depending on its source or the reason for which it was generated. To the contrary, this law positively assures that interested persons have the right to offer their technical expertise toward the solution of regulatory problems. Any proposal to subject scientific information generated for the purpose of a regulatory proceeding to more demanding standards than other scientific information considered in that proceeding would clash with this law and would face significant administrative complexities. In a closely related example, the U.S. Environmental Protection Agency considered but abandoned a program to implement standards aimed at “external” information

Mono- versus polydrug abuse patterns among publicly funded clients

To examine patterns of mono- versus polydrug abuse, data were obtained from intake records of 69,891 admissions to publicly funded treatment programs in Tennessee between 1998 and 2004. While descriptive statistics were employed to report frequency and patterns of mono- and polydrug abuse by demographic variables and by study years, bivariate logistic regression was applied to assess the probability of being a mono- or polydrug abuser for a number of demographic variables. The researchers found that during the study period 51.3% of admissions reported monodrug abuse and 48.7% reported polydrug abuse. Alcohol, cocaine, and marijuana were the most commonly abused substances, both alone and in combination. Odds ratio favored polydrug abuse for all but one drug category–other drugs. Gender did not affect drug abuse patterns; however, admissions for African Americans and those living in urban areas exhibited higher probabilities of polydrug abuse. Age group also appeared to affect drug abuse patterns, with higher odds of monodrug abuse among minors and adults over 45 years old. The discernable prevalence of polydrug abuse suggests a need for developing effective prevention strategies and treatment plans specific to polydrug abuse

An ethnographic study of Latino preschool children's oral health in rural California: Intersections among family, community, provider and regulatory sectors

<p>Abstract</p> <p>Background</p> <p>Latino children experience a higher prevalence of caries than do children in any other racial/ethnic group in the US. This paper examines the intersections among four societal sectors or contexts of care which contribute to oral health disparities for low-income, preschool Latino¹children in rural California.</p> <p>Methods</p> <p>Findings are reported from an ethnographic investigation, conducted in 2005–2006, of family, community, professional/dental and policy/regulatory sectors or contexts of care that play central roles in creating or sustaining low income, rural children's poor oral health status. The study community of around 9,000 people, predominantly of Mexican-American origin, was located in California's agricultural Central Valley. Observations in homes, community facilities, and dental offices within the region were supplemented by in-depth interviews with 30 key informants (such as dental professionals, health educators, child welfare agents, clinic administrators and regulatory agents) and 47 primary caregivers (mothers) of children at least one of whom was under 6 years of age.</p> <p>Results</p> <p>Caregivers did not always recognize visible signs of caries among their children, nor respond quickly unless children also complained of pain. Fluctuating seasonal eligibility for public health insurance intersected with limited community infrastructure and civic amenities, including lack of public transportation, to create difficulties in access to care. The non-fluoridated municipal water supply is not widely consumed because of fears about pesticide pollution. If the dentist brought children into the clinic for multiple visits, this caused the accompanying parent hardship and occasionally resulted in the loss of his or her job. Few general dentists had received specific training in how to handle young patients. Children's dental fear and poor provider-parent communication were exacerbated by a scarcity of dentists willing to serve rural low-income populations. Stringent state fiscal reimbursement policies further complicated the situation.</p> <p>Conclusion</p> <p>Several societal sectors or contexts of care significantly intersected to produce or sustain poor oral health care for children. Parental beliefs and practices, leading for example to delay in seeking care, were compounded by lack of key community or economic resources, and the organization and delivery of professional dental services. In the context of state-mandated policies and procedures, these all worked to militate against children receiving timely care that would considerably reduce oral health disparities among this highly disadvantaged population.</p