Audits and inspections are never enough: a critique to enhance food safety

Internal and external food safety audits are conducted to assess the safety and quality of food including on-farm production, manufacturing practices, sanitation, and hygiene. Some auditors are direct stakeholders that are employed by food establishments to conduct internal audits, while other auditors may represent the interests of a second party purchaser or a third-party auditing agency. Some buyers conduct their own audits or additional testing, while some buyers trust the results of third-party audits or inspections. Third-party auditors, however, use various food safety audit standards and most do not have a vested interest in the products being sold. Audits are conducted under a proprietary standard, while food safety inspections are generally conducted within a legal framework. There have been many foodborne illness outbreaks linked to food processors that have passed third-party audits and inspections, raising questions about the utility of both. Supporters argue third-party audits are a way to ensure food safety in an era of dwindling economic resources. Critics contend that while external audits and inspections can be a valuable tool to help ensure safe food, such activities represent only a snapshot in time. This paper identifies limitations of food safety inspections and audits and provides recommendations for strengthening the system, based on developing a strong food safety culture, including risk-based verification steps, throughout the food safety system

White Matter Hyperintensity Associations with Cerebral Blood Flow in Elderly Subjects Stratified by Cerebrovascular Risk

Objective: This study aims to add clarity to the relationship between deep and periventricular brain white matter hyperintensities (WMHs), cerebral blood flow (CBF), and cerebrovascular risk in older persons. Methods: Deep white matter hyperintensity (dWMH) and periventricular white matter hyperintensity (pWMH) and regional gray matter (GM) and white matter (WM) blood flow from arterial spin labeling were quantified from magnetic resonance imaging scans of 26 cognitively normal elderly subjects stratified by cerebrovascular disease (CVD) risk. Fluidattenuated inversion recovery images were acquired using a high-resolution 3-dimensional (3-D) sequence that reduced partial volume effects seen with slicebased techniques. Results: dWMHs but not pWMHs were increased in patients at high risk of CVD; pWMHs but not dWMHs were associated with decreased regional cortical (GM) blood flow. We also found that blood flow in WM is decreased in regions of both pWMH and dWMH, with a greater degree of decrease in pWMH areas. Conclusions: WMHs are usefully divided into dWMH and pWMH regions because they demonstrate differential effects. 3-D regional WMH volume is a potentially valuable marker for CVD based on associations with cortical CBF and WM CBF

In Solidarity

This edition of Next Page is a departure from our usual question and answer format with a featured campus reader. Instead, we asked speakers who participated in the College’s recent Student Solidarity Rally (March 1, 2017) to recommend readings that might further our understanding of the topics on which they spoke

Impact of operative indication and surgical complexity on outcomes after thoracic endovascular aortic repair at National Surgical Quality Improvement Program Centers

IntroductionThoracic endovascular aortic repair (TEVAR) devices are increasingly being utilized to treat aortic pathologies outside of the original Food & Drug Administration (FDA) approval for nonruptured descending thoracic aorta aneurysms (DTAs). The objective of this study was to evaluate the outcomes of patients undergoing TEVAR, elucidating the role of surgical and pathologic variables on morbidity and mortality.MethodsNational Surgical Quality Improvement Program (NSQIP) data were reviewed for all patients undergoing endovascular thoracic aorta repair from 2005 to 2007. The patients' operative indication and surgical complexity were used to divide them into study and control populations. Comorbid profiles were assessed utilizing a modified Charlson Comorbidity Index (CCI). Thirty-day occurrences of mortality and serious adverse events (SAEs) were used as study endpoints. Univariate and multivariate models were created using demographic and clinical variables to assess for significant differences in endpoints (P ≤ .05).ResultsA total of 440 patients undergoing TEVAR were identified. When evaluating patients based on operative indication, the ruptured population had increased mortality and SAE rates compared to the nonruptured DTA population (22.6% vs 6.2%;P < .01 and 35.5% vs 9.1%;P < .01, respectively). Further analysis by surgical complexity revealed increased mortality and SAE rates when comparing the brachiocephalic aortic debranching population to the noncovered left subclavian artery population (23.1% vs 6.5%; P = .02 and 30.8% vs 9.1%; P < .01, respectively). Multivariate analysis demonstrated that operative indication was not a correlate of mortality or SAEs (odds ratio [OR], 0.95; P = .92 and OR, 1.42; P = .39, respectively); however, brachiocephalic aortic debranching exhibited a deleterious effect on mortality (OR, 8.75; P < .01) and SAE rate (OR, 6.67; P = .01).ConclusionThe operative indication for a TEVAR procedure was not found to be a predictor of poor patient outcome. Surgical complexity, specifically the need for brachiocephalic aortic debranching and aortoiliac conduit, was shown to influence the occurrence of SAEs in a multivariate model. Comparative data, such as these, illustrate real-world outcomes of patients undergoing TEVAR outside of the original FDA-approved indications. This information is of paramount importance to various stakeholders, including third-party payers, the device industry, regulatory agencies, surgeons, and their patients

White Matter Diffusion Alterations in Normal Women at Risk of Alzheimer\u27s Disease

Increased white matter mean diffusivity and decreased fractional anisotropy (FA) has been observed in subjects diagnosed with mild cognitive impairment (MCI) and Alzheimer\u27s disease (AD). We sought to determine whether similar alterations of white matter occur in normal individuals at risk of AD. Diffusion tensor images were acquired in 42 cognitively normal right-handed women with both a family history of dementia and at least one apolipoprotein E4 allele. These were compared with images from 23 normal women without either AD risk factor. Group analyses were performed using tract-based spatial statistics. Reduced FA was observed in the fronto-occipital and inferior temporal fasciculi (particularly posteriorly), the splenium of the corpus callosum, subcallosal white matter and the cingulum bundle. These findings demonstrate that specific white matter pathways are altered in normal women at increased risk of AD years before the expected onset of cognitive symptoms

Neural measures of social attention across the first years of life: characterizing typical development and markers of autism risk

We would like to thank the Infant Sibling Project staff, past and present, for their hard work in collecting these data. We are very grateful for the assistance of Brandon Keehn, Alexandra Libby and Ella Kipervasser with data processing, and we thank Vanessa Vogel-Farley for her constant guidance. Finally, we want to acknowledge the very dedicated families who committed years of their lives to the Infant Sibling Project and who made this work possible. Funding was provided by NIH (R21DC08637) to H.T-F., NIDCD (1R01DC010290-01) to C.A.N. and H. T-F., the Simons Foundation (137186) to C.A.N. and the Autism Speaks Pilot Grants Program to H.T-F. (R21DC08637 - NIH; 1R01DC010290-01 - NIDCD; 137186 - Simons Foundation; Autism Speaks Pilot Grants Program)Published versio

Estimating the Sex Composition of the Summer Flounder Catch using Fishery-Independent Data

Models that account for sex-specific behavior and population dynamics are becoming more common in the stock assessment of sexually dimorphic fishes. However, such models can be data intensive and require some knowledge or assumptions about the sex ratio of fishery landings. A recent stock assessment review of Summer Flounder Paralichthys dentatus identified the need to account for sex-specific fishing mortality in the assessment model; however, no data on the sex composition of the catch were available. Fishery-independent, sex-specific information for this species is collected annually by the National Marine Fisheries Service\u27s Northeast Fisheries Science Center during their bottom trawl survey. Sex at age from the survey could be applied to the fishery landings if the probability of landing a given sex at a given age is equivalent for fish collected by the survey and those in the landings. To generate the first regionally comprehensive database on the sex ratio of Summer Flounder landings and to determine the efficacy of using survey sex-at-age keys to estimate the sex of landed fish, we recorded the sex composition of the commercial and recreational catches of Summer Flounder (n = 31,912) in 2010 and 2011. When (1) trawl survey length data were left-truncated to simulate the minimum retention sizes in the fisheries and (2) age-length keys generated from fishery-dependent data were applied to length frequency distributions from the survey to simulate the growth rates of landed fish, the sex-at-age pattern in the survey-derived data closely resembled the patterns in the catch. However, statistically significant differences in sex at age remained between the catch and the survey-derived data. We hypothesize that these differences are attributable to differences in the spatiotemporal distributions of the sexes and of the survey and fishing effort