Deliberate release: Plague – A review

An intensely debated question is whether or how a mandatory environmental risk assessment (ERA) should be conducted for plants obtained through novel genomic techniques, including genome editing (GE). Some countries have already exempted certain types of GE applications from their regulations addressing genetically modified organisms (GMOs). In the European Union, the European Court of Justice confirmed in 2018 that plants developed by novel genomic techniques for directed mutagenesis are regulated as GMOs. Thus, they have to undergo an ERA prior to deliberate release or being placed on the market. Recently, the European Food Safety Authority (EFSA) published two opinions on the relevance of the current EU ERA framework for GM plants obtained through novel genomic techniques (NGTs). Regarding GE plants, the opinions confirmed that the existing ERA framework is suitable in general and that the current ERA requirements need to be applied in a case specific manner. Since EFSA did not provide further guidance, this review addresses a couple of issues relevant for the case-specific assessment of GE plants. We discuss the suitability of general denominators of risk/safety and address characteristics of GE plants which require particular assessment approaches. We suggest integrating the following two sets of considerations into the ERA: considerations related to the traits developed by GE and considerations addressing the assessment of method-related unintended effects, e.g., due to off-target modifications. In conclusion, we recommend that further specific guidance for the ERA and monitoring should be developed to facilitate a focused assessment approach for GE plants.

Download Full-text

Emergency department response to the deliberate release of biological agents

Emergency Medicine Journal ◽

10.1136/emj.2003.005439 ◽

2004 ◽

Vol 21 (1) ◽

pp. 5-8 ◽

Cited By ~ 1

Author(s):

J E Ollerton

Keyword(s):

Emergency Department ◽

Biological Agents ◽

Deliberate Release

Download Full-text

The Reemergent 1977 H1N1 Strain and the Gain-of-Function Debate

mBio ◽

10.1128/mbio.01013-15 ◽

2015 ◽

Vol 6 (4) ◽

Cited By ~ 20

Author(s):

Michelle Rozo ◽

Gigi Kwik Gronvall

Keyword(s):

Vaccine Trial ◽

The United States ◽

Natural Occurrence ◽

Influenza Epidemic ◽

Gain Of Function ◽

Natural Event ◽

Policy Debates ◽

H1n1 Strain ◽

Deliberate Release ◽

Virus Research

ABSTRACTThe 1977-1978 influenza epidemic was probably not a natural event, as the genetic sequence of the virus was nearly identical to the sequences of decades-old strains. While there are several hypotheses that could explain its origin, the possibility that the 1977 epidemic resulted from a laboratory accident has recently gained popularity in discussions about the biosafety risks of gain-of-function (GOF) influenza virus research, as an argument for why this research should not be performed. There is now a moratorium in the United States on funding GOF research while the benefits and risks, including the potential for accident, are analyzed. Given the importance of this historical epidemic to ongoing policy debates, we revisit the evidence that the 1977 epidemic was not natural and examine three potential origins: a laboratory accident, a live-vaccine trial escape, or deliberate release as a biological weapon. Based on available evidence, the 1977 strain was indeed too closely matched to decades-old strains to likely be a natural occurrence. While the origin of the outbreak cannot be conclusively determined without additional evidence, there are very plausible alternatives to the laboratory accident hypothesis, diminishing the relevance of the 1977 experience to the modern GOF debate.

Download Full-text

Methodological Approach to the Study of Risk Policy Decision-Making: The Case of Deliberate Release of Genetically Engineered Organisms

Risk Assessment and Management ◽

10.1007/978-1-4757-6443-7_11 ◽

1987 ◽

pp. 99-106

Author(s):

Smita K. Siddhanti

Keyword(s):

Decision Making ◽

Methodological Approach ◽

Policy Decision ◽

Genetically Engineered ◽

Deliberate Release ◽

Policy Decision Making ◽

Genetically Engineered Organisms ◽

Risk Policy

Download Full-text

Effects of Alternative Blood Sources on Wolbachia Infected Aedes aegypti Females within and across Generations

Insects ◽

10.3390/insects9040140 ◽

2018 ◽

Vol 9 (4) ◽

pp. 140 ◽

Cited By ~ 4

Author(s):

Véronique Paris ◽

Ellen Cottingham ◽

Perran Ross ◽

Jason Axford ◽

Ary Hoffmann

Keyword(s):

Aedes Aegypti ◽

Human Blood ◽

Mass Rearing ◽

Egg Hatch ◽

Mass Release ◽

Deliberate Release ◽

Blood Source ◽

Wolbachia Density ◽

Infected Line ◽

Strong Adaptation

Wolbachia bacteria have been identified as a tool for reducing the transmission of arboviruses transmitted by Aedes aegypti. Research groups around the world are now mass rearing Wolbachia-infected Ae. aegypti for deliberate release. We investigated the fitness impact of a crucial element of mass rearing: the blood meal required by female Ae. aegypti to lay eggs. Although Ae. aegypti almost exclusively feed on human blood, it is often difficult to use human blood in disease-endemic settings. When females were fed on sheep or pig blood rather than human blood, egg hatch rates decreased in all three lines tested (uninfected, or infected by wMel, or wAlbB Wolbachia). This finding was particularly pronounced when fed on sheep blood, although fecundity was not affected. Some of these effects persisted after an additional generation on human blood. Attempts to keep populations on sheep and pig blood sources only partly succeeded, suggesting that strong adaptation is required to develop a stably infected line on an alternative blood source. There was a decrease in Wolbachia density when Ae. aegypti were fed on non-human blood sources. Density increased in lines kept for multiple generations on the alternate sources but was still reduced relative to lines kept on human blood. These findings suggest that sheep and pig blood will entail a cost when used for maintaining Wolbachia-infected Ae. aegypti. These costs should be taken into account when planning mass release programs.

Download Full-text

The reintroduction, and subsequent impact, of rabbit haemorrhagic disease virus in a population of wild rabbits in south-western Australia

Wildlife Research ◽

10.1071/wr04025 ◽

2005 ◽

Vol 32 (2) ◽

pp. 139 ◽

Cited By ~ 11

Author(s):

John S. Bruce ◽

Laurie E. Twigg

Keyword(s):

Disease Virus ◽

Western Australia ◽

Morbidity Rate ◽

Rabbit Haemorrhagic Disease Virus ◽

Rabbit Population ◽

Rabbit Haemorrhagic Disease ◽

Deliberate Release ◽

Haemorrhagic Disease ◽

The Impact ◽

Variable Impact

The natural arrival of rabbit haemorrhagic disease virus (RHDV) in south-western Australia in September 1996 resulted in a reduction in rabbit numbers of ~65% (~90% morbidity, with ~72% mortality of infected rabbits). As no signs of the disease (clinical or serological) were seen over the next two years, and as rabbit numbers over the last 12-month monitoring period at the site were similar to those observed before the natural 1996 RHDV epizootic (i.e. pre-RHD), RHDV was deliberately reintroduced into this rabbit population in April 1999 (autumn). Seven RHDV-inoculated rabbits were released prior to the main breeding season when <3% of sampled rabbits (n = 118) were seropositive for RHDV antibodies. Following the deliberate release, the overall decline in rabbit numbers (68%) was comparable to that seen during the natural 1996 epizootic. However, on the basis of the observed changes in rabbit numbers, and in their serology, the impact of the deliberate RHDV release appeared to be more variable across the six trapping areas than was seen during the natural 1996 spring epizootic. The reductions in rabbit numbers on these areas 6–8 weeks after RHDV-release ranged from 55% to 90%. The serology of the surviving rabbits on the trapping areas was also variable over this period, with the proportion of seropositive rabbits ranging from 5% to 90%. Overall, only 15% of the surviving rabbit population showed evidence of recent challenge by RHDV, giving a morbidity rate of 73% 8 weeks after the release. However, over 90% of infected rabbits died. This provides further evidence that some rabbits remained un-challenged by RHDV for up to 8 weeks after its release. The variable impact of the April 1999 release may have been partially caused by the observed differences in abundance of insect vectors, and/or an apparent increase in the incidence of non-virulent RHDV in the months preceding the release.

Download Full-text