GAO: FDA clearinghouse for produce industry slow to respond
A clearinghouse that the US Food and Drug Administration (FDA) set up to take questions from industry and stakeholders about a new rule that established the food safety standards for the produce industry is slow to answer questions, according to a Government Accountability Office (GAO) report released Nov 28. The produce rule is part of the FDA Food Safety Modernization Act, passed in 2011.
Some members of the produce industry have raised concerns about the new food safety standards, especially regarding the scientific basis and the costs of meeting the standards. The GAO's investigation into the businesses concerns regarding the FDA's produce rule was written into the 2014 Farm Bill.
The latest report covers the produce rule clearinghouse, called the Technical Assistance Network (TAN), which received 2,626 questions from early September 2015 through early September 2016. About 14% of the questions related to the produce rule, with about 60% of them coming from the produce industry. As of early October, the agency had responded to 72% of the questions. The median response time was 22 days.
According to the report, FDA officials said some of the delays were because guidance was still under development, and answers through the TAN might have conflicted with final guidance. The FDA had ways to notify people about delays and is working to narrow the response time. FDA officials also said they are working on a stakeholder survey to assess the effectiveness of the TAN. The GAO sent its report to Senate and House committees that address food safety issues.
Nov 28 GAO report
Oman reports 10th MERS case
Oman's health ministry announced a new MERS-CoV case yesterday involving a 67-year-old man who is a citizen and has recovered already, the Times of Oman reported.
Few details were available, other than that the man had an acute respiratory infection and was treated at a local government hospital.
The case marks Oman's tenth MERS-CoV (Middle East respiratory syndrome coronavirus) illness and its first case since January. The infection lifts the global total from the disease to 1,864, according to a case list maintained by FluTrackers, an infectious disease news message board.
Nov 29 Times of Oman report
FluTrackers MERS-CoV case list
Novel group A Strep strain implicated in Alaskan outbreak
The Alaska Department of Health and Social Services (ADHSS) yesterday said its epidemiology section is working with the Centers for Disease Control and Prevention (CDC) and the city of Anchorage to investigate an outbreak of invasive group A Streptococcus (GAS) caused by a new genotype, emm-type 26 that has left four dead.
According to a public health advisory, 28 cases have been confirmed, including 10 in Fairbanks and 18 in Anchorage. Fourteen of the cases were detected in October and November, and most of Anchorage's cases have involved homeless men who have a history of alcohol abuse.
Officials urged health providers to be alert for signs and symptoms of invasive GAS infections and have notified homeless service providers in the Anchorage area. Symptoms can include pharyngitis and skin infections but can also involve severe problems such as sepsis, necrotizing fasciitis, and streptococcal shock syndrome (STSS). People can contract GAS through contact with respiratory secretions or the skin of colonized patients.
Of Alaska's patients, 8 had necrotizing fasciitis, 3 had STSS, and 4 have died.
Joe McLaughlin, MD, MPH, Alaska's state epidemiologist, told the Alaska Daily News (ADN) yesterday that new GAS strains aren't commonly identified, and when they are, they're usually linked to outbreaks, because people haven't developed immunity to them. He also told the paper that certain racial demographic groups, including Native Americans, appear to be more susceptible to GAS infections and that Alaska's outbreak has mostly affected middle-aged Alaska Native men.
Nov 29 ADHSS public health advisory
Nov 29 ADN story
Additives allow vaccines to stay at room temperature longer
A new study in Nature Communications examines three novel ways to store viral-vector vaccines at room-temperature, a potential game-changer for transporting these vaccines without refrigeration. Experiments showed that low-cost additives maintained immunogenicity in vivo for viruses stored for 10 days at 37 °C, compared with 2 to 3 days at 2°C to 8°C.
Without refrigeration, most viral-vector vaccines begin to break down and lose integrity within hours, so researchers at Ecole Polytechnique Federale de Lausanne's (EPFL's) Supramolecular Nanomaterials and Interfaces Laboratory used minute quantities of nanoparticles, an FDA-approved polymer (polyethylene glycol), or higher amounts of sucrose, to stabilize vaccines.
Adding sucrose, a sugar, to increase the vaccine's viscosity extended the stability of the vaccine to 70 days. Polymers extended vaccine integrity to 20 days, and nanoparticles extended a vaccine's half-life to 20 days.
The researchers tested their three methods with a chikungunya vaccine in mice, and showed that they could maintain structural vaccine integrity for up to 10 days.
"This study could be a starting point to develop more solutions for the stabilization of viral particles, depending on the specific medical need of virus-based applications (that is, vaccines, therapies and viral gene delivery systems)," the authors concluded.
Nov 30 Nat Comm study
Nov 30 EPFL press release
UK scientists create cloud-based, real-time outbreak tracking tool
Scientists from the Wellcome Trust Sanger Institute and Imperial College London have developed Microreact, a free, real-time, cloud-based epidemic tracking program that has been used to monitor outbreaks of Ebola, Zika, and antibiotic-resistant microbes, according to a study today in Microbial Genomics.
The concept allows researchers around the world to share their latest information about disease outbreaks, according to a Wellcome Trust press release. Microreact combines the power of open data and the Internet to provide real-time global data sharing and visualization, allowing anyone to explore and examine outbreak information rapidly and in detail.
David Aanensen, PhD, director of the Centre for Genomic Pathogen Surveillance—a joint initiative between Imperial College London and the Sanger Institute—and one of Microreact's creators, said, "Until now, the global research community has been hamstrung because results are generally only shared in static pictures or tables in publications. Microreact allows everyone to explore the information dynamically—across both time and space—letting them see the whole picture.
"Using Microreact takes disease tracking out the hands of a privileged few and gives it to everyone who wants to understand disease evolution."
Nov 30 Microb Genom study
Nov 30 Wellcome Trust news release