Integrating safety, security, sustainability, and social responsibility principles into the U.S. bioeconomy.

Bioindustrial manufacturing is undergoing rapid expansion and investment and is seen as integral to nations' economic progress. Ensuring that bioindustrial manufacturing benefits society as the field expands is of critical, urgent importance. To better understand the industry's ethical trajectory and to shape policy, we explored the views of biotechnology leaders on four aspects of ethical and social responsibility-safety, security, social responsibility, and sustainability-what we have termed "4S principles." We identified policy actions governments and other stakeholders may take to maximize societal benefits in industrial biotechnology. IMPORTANCE: We analyzed biotech leaders' views on safety, security, social responsibility, and sustainability to recommend policies to maximize benefits and economic growth.

Priorities for Public-Private Cooperation to Mitigate Risk and Impact of Global Catastrophic Biological Risks.

By definition, Global Catastrophic Biological Risks (GCBRs) are "beyond the collective capability of national and international governments and the private sector to control". Implicit in this definition is that no single country, sector, or entity can effectively mitigate risk and impact of GCBRs and that doing so requires public-private cooperation. This short commentary offers five trends suggesting that conditions for cooperation are favorable, along with three gaps to be addressed, and five high-level recommendations to strengthen public-private cooperation to mitigate risk and impact of GCBRs.

GHSI EMERGENCY RADIONUCLIDE BIOASSAY LABORATORY NETWORK - SUMMARY OF THE SECOND EXERCISE.

The Global Health Security Initiative (GHSI) established a laboratory network within the GHSI community to develop collective surge capacity for radionuclide bioassay in response to a radiological or nuclear emergency as a means of enhancing response capability, health outcomes and community resilience. GHSI partners conducted an exercise in collaboration with the WHO Radiation Emergency Medical Preparedness and Assistance Network and the IAEA Response and Assistance Network, to test the participating laboratories (18) for their capabilities in in vitro assay of biological samples, using a urine sample spiked with multiple high-risk radionuclides (90Sr, 106Ru, 137Cs, and 239Pu). Laboratories were required to submit their reports within 72 h following receipt of the sample, using a pre-formatted template, on the procedures, methods and techniques used to identify and quantify the radionuclides in the sample, as well as the bioassay results with a 95% confidence interval. All of the participating laboratories identified and measured all or some of the radionuclides in the sample. However, gaps were identified in both the procedures used to assay multiple radionuclides in one sample, as well as in the methods or techniques used to assay specific radionuclides in urine. Two-third of the participating laboratories had difficulties in determining all the radionuclides in the sample. Results from this exercise indicate that challenges remain with respect to ensuring that results are delivered in a timely, consistent and reliable manner to support medical interventions. Laboratories within the networks are encouraged to work together to develop and maintain collective capabilities and capacity for emergency bioassay, which is an important component of radiation emergency response.

GHSI EMERGENCY RADIONUCLIDE BIOASSAY LABORATORY NETWORK: SUMMARY OF A RECENT EXERCISE.

The Global Health Security Initiative (GHSI) established a laboratory network within the GHSI community to develop their collective surge capacity for radionuclide bioassay in response to a radiological or nuclear emergency. A recent exercise was conducted to test the participating laboratories for their capabilities in screening and in vitro assay of biological samples, performing internal dose assessment and providing advice on medical intervention, if necessary, using a urine sample spiked with a single radionuclide, 241Am. The laboratories were required to submit their reports according to the exercise schedule and using pre-formatted templates. Generally, the participating laboratories were found to be capable with respect to rapidly screening samples for radionuclide contamination, measuring the radionuclide in the samples, assessing the intake and radiation dose, and providing advice on medical intervention. However, gaps in bioassay measurement and dose assessment have been identified. The network may take steps to ensure that procedures and practices within this network be harmonised and a follow-up exercise be organised on a larger scale, with potential participation of laboratories from the networks coordinated by the International Atomic Energy Agency and the World Health Organization.

Legal and regulatory capacity to support the global health security agenda.

On February 13, 2014, 27 nations, along with 3 international organizations, launched the Global Health Security Agenda (GHSA). The intent of GHSA is to accelerate progress in enabling countries around the world to prevent, detect, and respond to public health emergencies-capacities to be achieved through 9 core objectives. Building national, regional, and international capacity includes creating strong legal and regulatory regimes to support national and international capacities to prevent, detect, and respond to public health emergencies. Accordingly, establishing and reinforcing international and national-level legal preparedness is central to advancing elements of each of the 9 objectives of the GHSA.

Medical reserve corps volunteers in disasters: a survey of their roles, experiences, and challenges.

The Medical Reserve Corps (MRC) was established in the Office of the Surgeon General in response to the spontaneous but disorganized outpouring of medical volunteers following the terrorist attacks of 2001. The mission of the federal MRC office is to provide organizational structure and guidance to the nearly 1,000 locally organized and funded MRC units that have grown up across the country and the more than 200,000 volunteer health professionals that staff these units. Despite the large size of this program and its numerous activations over the past decade, including in the Boston Marathon bombing and Hurricane Sandy, relatively little is known about the MRC, including the make-up of the units, the ways units have been used, and the challenges faced by MRC units and their volunteers. Here we report the results of a mixed-methods investigation of MRC unit organization, activities, and challenges.

Absorbing citywide patient surge during Hurricane Sandy: a case study in accommodating multiple hospital evacuations.

STUDY OBJECTIVE: Hospital evacuations have myriad effects on all elements of the health care system. We seek to (1) examine the effect of patient surge on hospitals that received patients from evacuating hospitals in New York City during Hurricane Sandy; (2) describe operational challenges those hospitals faced pre- and poststorm; and (3) examine the coordination efforts to distribute patients to receiving hospitals. METHODS: We used a qualitative, interview-based method to identify medical surge strategies used at hospitals receiving patients from evacuated health care facilities during and after Hurricane Sandy. We identified 4 hospital systems that received the majority of evacuated patients and those departments most involved in managing patient surge. We invited key staff at those hospitals to participate in on-site group interviews. RESULTS: We interviewed 71 key individuals. Although all hospitals had emergency preparedness plans in place before Hurricane Sandy, we identified gaps. Insights gleaned included improvement opportunities in these areas: prolonged increased patient volume, an increase in the number of methadone and dialysis patients, ability to absorb displaced staff, the challenges associated with nursing homes that have evacuated and shelters that have already reached capacity, and reimbursements for transferred patients. CONCLUSION: Our qualitative, event-based research identified key opportunities to improve disaster preparedness. The specific opportunities and this structured postevent approach can serve to guide future disaster planning and analyses.

Emergency Preparedness in the 10-Mile Emergency Planning Zone Surrounding Nuclear Power Plants.

OBJECTIVES: Each of the nuclear power plants in the US is encircled by an Emergency Planning Zone (EPZ). Within each EPZ, government officials, utility professionals, emergency managers, and public health practitioners collectively conduct extensive planning, exercises, and outreach to better protect their communities in the event of a nuclear accident. Our objective was to conduct a cross-sectional study of off-site public health preparedness within EPZs to better understand the dynamics of nuclear preparedness and uncover lessons for all-hazards preparedness. METHODS: Using a qualitative, interview-based method, we consulted 120 county emergency managers, state health preparedness officers, state radiation health officials, and industry officials from 17 EPZs in ten different states. RESULTS: Interviewees reflected that EPZ emergency preparedness is generally robust, results from strong public-private partnership between nuclear plants and emergency management agencies, and enhances all-hazard preparedness. However, there exist a few areas which merit further study and improvement. These areas include cross-state coordination, digital public communication, and optimizing the level of public education within EPZs. CONCLUSIONS: This first-of-its-kind study provides a cross-sectional snapshot of emergency preparedness in the 10-mile EPZ surrounding nuclear power plants.

Local health department capacity for community engagement and its implications for disaster resilience.

Over the past decade, community engagement has become a central tenet of US federal doctrine on public health emergency preparedness. Little is known, however, about how the vision of a ready, aware, and involved populace has translated into local practice, or which conditions thus far have advanced community involvement in what is typically considered the province of government authorities and emergency professionals. In 2011-12, to help close that knowledge gap, investigators carried out semistructured qualitative interviews with practitioners (N=25) from 7 local health departments about which conditions have advanced or inhibited community engagement in public health emergency preparedness. Among the organizational factors identified as enabling local health departments' involvement of community residents and groups in emergency preparedness were a supportive agency leadership and culture, sufficient staffing and programmatic funding, interested and willing partners, and external triggers such as federal grants and disaster experiences that spotlighted the importance of community relationships to effective response. Facing budget and staff cuts, local health departments feel increasingly constrained in efforts to build trusted and lasting preparedness ties with community partners. At the same time, some progress in preparedness partnerships may be possible in the context of agency leadership, culture, and climate that affirms the value of collaboration with the community.

After Fukushima: managing the consequences of a radiological release.

Even amidst the devastation following the earthquake and tsunami in Japan that killed more than 20,000 people, it was the accident at the Fukushima Daiichi nuclear power plant that led the country's prime minister, Naoto Kan, to fear for "the very existence of the Japanese nation." While accidents that result in mass radiological releases have been rare throughout the operating histories of existing nuclear power plants, the growing number of plants worldwide increases the likelihood that such releases will occur again in the future. Nuclear power is an important source of energy in the U.S. and will be for the foreseeable future. Accidents far smaller in scale than the one in Fukushima could have major societal consequences. Given the extensive, ongoing Nuclear Regulatory Commission (NRC) and industry assessment of nuclear power plant safety and preparedness issues, the Center for Biosecurity of UPMC focused on offsite policies and plans intended to reduce radiation exposure to the public in the aftermath of an accident. This report provides an assessment of Japan's efforts at nuclear consequence management; identifies concerns with current U.S. policies and practices for "outside the fence" management of such an event in the U.S.; and makes recommendations for steps that can be taken to strengthen U.S. government, industry, and community response to large-scale accidents at nuclear power plants.

Intravenous hydrogen sulfide does not induce hypothermia or improve survival from hemorrhagic shock in pigs.

Several laboratory studies suggested that induced hypothermia during hemorrhagic shock improves survival. Inhaled hydrogen sulfide (H2S) induced hypothermia and decreased metabolism in mice and rats but not in piglets. We tested the hypothesis that i.v. H2S will induce hypothermia, reduce oxygen consumption (VO2), and improve outcome in prolonged hemorrhagic shock in pigs. We also assessed markers of organ injury (alanine aminotransferase, aspartate aminotransferase, creatine phosphokinase, creatinine, and troponin) and level of protein thiols to monitor H2S metabolism. In a prospective randomized study, pigs were subjected to volume-controlled hemorrhagic shock with limited fluid resuscitation to maintain MAP 30 mmHg or greater. The study group received infusion of H2S at 5 mg·kg·h; the control group received vehicle (n = 8 per group). Dose was based on the highest tolerated dose in pilot studies. Full resuscitation was initiated after 3 h. There were no differences in survival at 24 h between groups (2/8 in H2S vs. 3/8 in control group). Heart rate increased similarly during hemorrhagic shock in both groups. Cardiac output was better preserved in the delayed phase of hemorrhagic shock in the control group. Temperature and VO2 were similar in both groups during hemorrhagic shock and resuscitation. Markers of organ injury and protein thiols markedly increased in both groups with no differences between groups. In conclusion, we were not able to demonstrate the hypothermia-inducing effect or a reduction in VO2 from H2S infusion in our model of hemorrhagic shock in pigs. Our data mirror those seen in piglets and provide additional evidence of difficulty in translating the hypothermia effect of H2S to large animals in a clinically relevant postinsult paradigm.

Expanding practitioner scopes of practice during public health emergencies: experiences from the 2009 H1N1 pandemic vaccination efforts.

In a public health emergency involving significant surges in patients and shortages of medical staff, supplies, and space, temporarily expanding scopes of practice of certain healthcare practitioners may help to address heightened population health needs. Scopes of practice, which are defined by state practice acts, set forth the range of services that licensed practitioners are authorized to perform. The U.S. has had limited experience with temporarily expanding scopes of practice during emergencies. However, during the 2009 H1N1 pandemic response, many states took some form of action to expand the practice scopes of certain categories of practitioners in order to authorize them to administer the pandemic vaccine. No standard legal approach for expanding scopes of practice during emergencies exists across states, and scope of practice expansions during routine, nonemergency times have been the subject of professional society debate and legal action. These issues raise the question of how states could effectively implement expansions for health services beyond administering vaccine and ensure consistency in expansions across states during catastrophic events that require a shift to crisis standards of care. This article provides an overview of scopes of practice, a summary of the range of legal and regulatory approaches used in the U.S. to expand practice scopes for vaccination during the 2009 H1N1 response, and recommendations for future research.

Assessment of the delta opioid agonist DADLE in a rat model of lethal hemorrhage treated by emergency preservation and resuscitation.

Emergency preservation and resuscitation (EPR) is a new approach for resuscitation of exsanguination cardiac arrest (CA) victims. EPR uses a cold aortic flush to induce deep hypothermic preservation during no-flow to buy time for transport and damage control surgery, followed by resuscitation with cardiopulmonary bypass (CPB). We reported previously that 20-60 min EPR in rats was associated with intact outcome, while 75 min EPR resulted in high mortality and neurological impairment in survivors. The delta opioid agonist DADLE ([D-Ala(2),D-Leu(5)]-enkephalin) was shown previously to be protective against ischemia-reperfusion injury in multiple organs, including brain. We hypothesized that DADLE could augment neurological outcome after EPR in rats. After rapid lethal hemorrhage, EPR was initiated by perfusion with ice-cold crystalloid to induce hypothermia (15 degrees C). After 75 min EPR, resuscitation was attempted with CPB. After randomization, three groups were studied (n=10 per group): DADLE 0mg/kg (D0), 4 mg/kg (D4) or 10mg/kg (D10) added to the flush and during reperfusion. Survival, overall performance category (OPC; 1=normal, 5=death), neurological deficit score (NDS; 0-10% normal, 100%=max deficit), and histological damage score (HDS) were assessed in survivors on day 3. In D0 group, 2/10 rats survived, while in D4 and D10 groups, 4/10 and 5/10 rats survived, respectively (p=NS). Survival time (h) was 26.7+/-28.2 in D0, 36.3+/-31.9 in D4 and 47.1+/-30.3 in D10 groups, respectively (p=0.3). OPC, NDS and HDS were not significantly different between groups. In conclusion, DADLE failed to confer benefit on functional or histological outcome in our model of prolonged rat EPR.