Office of Regulatory Affairs Strategies for Building an Integrated National Laboratory Network for Food and Feed

An interconnected network of accredited federal, state, local, tribal, and territorial laboratories is critical to ensuring the safety of the U.S. food supply and the development of the Integrated Food Safety System (IFSS). In 2004, as part of a national policy to defend the U.S. food supply against terrorist attacks, major disasters, and other emergencies, the Food Emergency Response Network (FERN) was created to integrate the nation’s multilevel (i.e., federal, state, local, tribal, territorial) food-testing laboratories to detect, identify, respond to, and recover from a bioterrorism act affecting the safety of the food supply, or a public health emergency/outbreak involving the food supply. Since 2004, federal agencies have invested an estimated $200 million in FERN. The majority of this investment has been in the FERN cooperative agreements with FDA and USDA-FSIS investing$95.8 million and $69 million, respectively. FDA has promoted the accreditation of state laboratories through cooperative agreement funding, investing more than$50 million to fund these grants. On November 11, 2014, the Office of Regulatory Affairs (ORA) requested that the FDA Science Board establish a subcommittee to evaluate current investments in: (1) the FERN cooperative agreement funding program (CAP), and (2) funding for state laboratories to achieve International Organization for Standardization (ISO) accreditation. The goal was to ascertain how ORA can advance and establish an effective integrated laboratory network among ORA, FDA Center, and state public health and food- and feed-testing laboratories. In response to this request, the Science Board created the ORA FERN Cooperative Agreement Evaluation Subcommittee on July 1, 2015. This report summarizes the results of the Subcommittee’s review

Just plain Wronga?: a multimodal critical analysis of online payday loan discourse

Payday loans constitute one of the most rapidly expanding and controversial forms of consumer lending today. Payday lending – the selling of high-interest, short-term credit – has thrived in the wake of the decline of the traditional high street banking system and the reluctance on the part of many mainstream credit services, following the 2007/8 Global Financial Crisis, to lend to low income earners. This study critically examines the website of the industry leader in the UK, Wonga, a payday lender which recently rebranded and relaunched itself (in 2015) after being embroiled in a series of financial scandals. Our analysis centres on the new Wonga website, the gateway to its financial services, and identifies three inter-related discursive strategies through which the lender, in the wake of its financial misconduct, seeks to present itself as a reputable financial service provider, namely by (1) constructing the empowered and responsible borrower, (2) de-stigmatising both its service provision and its prospective customers, the payday borrower, and (3) minimising the consequences and risks associated with payday borrowing. We argue that, collectively, these strategies constitute an artful response by Wonga to the changing legislative and socio-economic contexts in which it and other payday lenders are now required to operate, permitting it to continue marketing and selling its high-interest rate financial services

Roadwork:Expertise at work building roads in the Maldives

This article engages critically with concepts of ‘skill’, ‘expertise’, and ‘capacity’ as they operate as markers of distinction and domination and shape migratory labour relations among road construction workers from across South Asia in the Maldives archipelago. The article examines roadwork at three levels: the professional biographies leading to ‘flexible specialization’ rather than technical expertise amongst Maldivian managers; the technical expertise and social incorporation of ‘skilled’ Sri Lankan supervisors; and the key material expertise of ‘non-skilled’ Bangladeshi labourers in precarious employment. Whilst discussions of South Asian labour migration have been dominated by caste and class, this article argues that it is important to consider how the cultural production and understanding of concepts such as ‘expertise’, ‘capacity’, and ‘exposure’ at worksites can (also) become distinguishing factors in (hierarchical) migratory labour relations

Surface Sampling Methods for Bacillus anthracis Spore Contamination

During an investigation conducted December 17–20, 2001, we collected environmental samples from a U.S. postal facility in Washington, D.C., known to be extensively contaminated with Bacillus anthracis spores. Because methods for collecting and analyzing B. anthracis spores have not yet been validated, our objective was to compare the relative effectiveness of sampling methods used for collecting spores from contaminated surfaces. Comparison of wipe, wet and dry swab, and HEPA vacuum sock samples on nonporous surfaces indicated good agreement between results with HEPA vacuum and wipe samples. However, results from HEPA vacuum sock and wipe samples agreed poorly with the swab samples. Dry swabs failed to detect spores >75% of the time they were detected by wipe and HEPA vacuum samples. Wipe samples collected after HEPA vacuum samples and HEPA vacuum samples after wipe samples indicated that neither method completely removed spores from the sampled surfaces

Climate-driven regime shift of a temperate marine ecosystem.

Ecosystem reconfigurations arising from climate-driven changes in species distributions are expected to have profound ecological, social, and economic implications. Here we reveal a rapid climate-driven regime shift of Australian temperate reef communities, which lost their defining kelp forests and became dominated by persistent seaweed turfs. After decades of ocean warming, extreme marine heat waves forced a 100-kilometer range contraction of extensive kelp forests and saw temperate species replaced by seaweeds, invertebrates, corals, and fishes characteristic of subtropical and tropical waters. This community-wide tropicalization fundamentally altered key ecological processes, suppressing the recovery of kelp forests

Efficacy and safety of a subacromial continuous ropivacaine infusion for post-operative pain management following arthroscopic rotator cuff surgery: A protocol for a randomised double-blind placebo-controlled trial

<p>Abstract</p> <p>Background</p> <p>Major shoulder surgery often results in severe post-operative pain and a variety of interventions have been developed in an attempt to address this. The continuous slow infusion of a local anaesthetic directly into the operative site has recently gained popularity but it is expensive and as yet there is little conclusive evidence that it provides additional benefits over other methods of post-operative pain management.</p> <p>Methods/Design</p> <p>This will be a randomised, placebo-controlled trial involving 158 participants. Following diagnostic arthroscopy, all participants will undergo arthroscopic subacromial decompression with or without rotator cuff repair, all operations performed by a single surgeon. Participants, the surgeon, nurses caring for the patients and outcome assessors will be blinded to treatment allocation. All participants will receive a pre-incision bolus injection of 20 mls of ropivacaine 1% into the shoulder and an intra-operative intravenous bolus of parecoxib 40 mg. Using concealed allocation participants will be randomly assigned to active treatment (local anaesthetic ropivacaine 0.75%) or placebo (normal saline) administered continuously into the subacromial space by an elastomeric pump at 5 mls per hour post-operatively. Patient controlled opioid analgesia and oral analgesics will be available for breakthrough pain. Outcome assessment will be at 15, 30 and 60 minutes, 2, 4, 8, 12, 18 and 24 hours, and 2 or 4 months for decompression or decompression plus repair respectively.</p> <p>The primary end point will be average pain at rest over the first 12-hour post-operative period on a verbal analogue pain score. Secondary end points will be average pain at rest over the second 12-hour post-operative period, maximal pain at rest over the first and second 12-hour periods, amount of rescue medication used, length of inpatient stay and incidence of post-operative adhesive capsulitis.</p> <p>Discussion</p> <p>The results of this trial will contribute to evidence-based recommendations for the effectiveness of pain management modalities following arthroscopic rotator cuff surgery. If the local anaesthetic pain-buster provides no additional benefits over placebo then valuable resources can be put to better use in other ways.</p> <p>Trial registration</p> <p>Australian Clinical Trials Register Number ACTR12606000195550</p

The sinus tarsi approach in displaced intra-articular calcaneal fractures: a systematic review

Purpose: Although open reduction and internal fixation is currently considered the gold standard in surgical treatment of displaced intra-articular calcaneal fractures, various different approaches exist including the limited lateral approach. The aim of this systematic review was to combine the results of studies using the sinus tarsi approach, which is the most frequently applied limited lateral approach. Method: A literature search in the electronic databases of the Cochrane Library and Pubmed Medline, between January 1st 2000 to December 1st 2010, was conducted to identify studies in which the sinus tarsi approach or a modified sinus tarsi approach was utilized for the treatment of displaced intra-articular calcaneal fractures. The methodological quality of the included studies was assessed using the Coleman methodology score. Results: A total of eight case series reporting on 256 patients with 271 calcaneal fractures was identified. Overall good to excellent outcome was reached in three-quarters of all patients. An average complication rate of minor wound complications of 4.1% was reported and major wound complications in 0.7%. The need for a secondary subtalar arthrodesis occurred at an average rate of 4.3%. The average Coleman methodology score was 56.8 (range 39-72) points. Conclusion: The results, i.e. functional outcome and complication rates, of the sinus tarsi approach compare similarly or favourably to the extended lateral approach. Therefore, in the process of tailoring the best treatment modality to the right patient and the right fracture type, the sinus tarsi approach might be a valuable asset

Close encounters: ritualizing proximity in the Age of Celebrity. An ethnographic analysis of meet-and-greets with Dutch singer Marco Borsato

Abstract For many celebrities, organizing meet-and-greets with fans and followers has become a permanent feature of their public appearances. As yet little is known about the role and importance of such ‘unmediated’ encounters within the everyday constitution of celebrity culture. Why would fans be interested in the possibility of direct, personal contact with people they already know from the media? To find an answer to this question, this article presents ethnographic research into meet-andgreets with the Dutch artist Marco Borsato. Results show that these meet-and-greets constitute a meaningful experience for those involved: they validate and enhance emotional involvement, serve as status symbols within the fan hierarchy and, in some cases, can fulfil a vital role in personal life narratives of healing

Transverse momentum and centrality dependence of dihadron correlations in Au+Au collisions at sqrt(s_NN)=200 GeV: Jet-quenching and the response of partonic matter

Azimuthal angle \Delta\phi correlations are presented for charged hadrons from dijets for 0.4 < p_T < 10 GeV/c in Au+Au collisions at sqrt(s_NN) = 200 GeV. With increasing p_T, the away-side distribution evolves from a broad to a concave shape, then to a convex shape. Comparisons to p+p data suggest that the away-side can be divided into a partially suppressed "head" region centered at Delta\phi ~ \pi, and an enhanced "shoulder" region centered at Delta\phi ~ \pi +/- 1.1. The p_T spectrum for the "head" region softens toward central collisions, consistent with the onset of jet quenching. The spectral slope for the "shoulder" region is independent of centrality and trigger p_T, which offers constraints on energy transport mechanisms and suggests that the "shoulder" region contains the medium response to energetic jets.Comment: 420 authors from 58 institutions, 6 pages, 4 figures. Submitted to Physical Review Letters. Plain text data tables for the points plotted in figures for this and previous PHENIX publications are (or will be) publicly available at http://www.phenix.bnl.gov/papers.htm