Mapping Uncertainties in the Upstream: The Case of PLGA Nanoparticles in Salmon Vaccines

Abstract

The diversity of nanotechnologies and of the governance challenges that their applications raise calls for exploration and learning across different cases. We present an Upstream Oversight Assessment (UOA) of expected benefits and potential harms of nanoparticles made of a synthetic polymer (PLGA) to improve vaccines for farmed salmon. Suggested by Jennifer Kuzma and colleagues, an UOA may help identify and prioritise research needs, and it may support evaluations of the adequacy of relevant existing regulatory frameworks. In this work, the UOA approach is modified and supported with elements from the uncertainty analysis framework developed by Warren Walker and colleagues. Empirically, we draw on relevant available published literature and insights generated in an ongoing nanoparticle salmon vaccine project, in which one of the authors participates. Nanotechnologies have not previously been encountered in the regulatory context of fish vaccines, which in part raises unique challenges due to prospective large scale vaccine use in semi-open aquatic systems. Strengthened through cooperation between ELSA and technology researchers we found the UOA useful for an early mapping of benefits and concerns, and for identifying areas in need of further research prior to a nanoparticle based salmon vaccine is developed and taken into use. We consider our approach to represent one among several complementing initiatives that seek to contribute to early stage evaluations of possible negative side effects, broadly conceived, in order to facilitate a more robust nanotechnology development.

Four approaches to anticipatory climate governance: Different conceptions of the future and implications for the present

“…David Guston, a leading scholar in this tradition, defines anticipatory governance as “a broad‐based capacity extended through society that can act on a variety of inputs to manage emerging knowledge‐based technologies while such management is still possible” (Guston, 2014, p. 219). In this view, anticipatory governance is a nonpredictive approach to enhance present‐day preparedness, including through building capacities in foresight and multi‐stakeholder engagement, all to steer away from possible disruptive impacts of novel technologies in the future (Anderson, 2007; Barben et al, 2008; Guston, 2012, 2014; Nielsen, Fredriksen, & Myhr, 2011; Stilgoe et al, 2013). The future is conceived here as being inherently uncertain but which can nonetheless be acted upon in the present, with a focus on building society‐wide capacities to anticipate and navigate future trajectories.…”

Strategies and hurdles using DNA vaccines to fish

“…Five aspects were taken into consideration before the vaccine was approved: (i) public perception and acceptance, (ii) regulatory and environmental concerns, (iii) risk-benefit, (iv) feasibility of producing the vaccine at a scale and cost appropriate for the fish industry, and (v) intellectual property issues [91]. At present there has not been approved any DNA vaccine to be used in aquaculture in Europe.…”

“…In vitro studies using PLGA nano- and micro-particles have so far not revealed any toxic effects, even at large doses [ 90 ]. The various concerns regarding the use of PLGA particles in aquaculture vaccines have recently been reviewed by Nielsen et al [ 91 ].…”

“…The Canadian Food Inspection Agency (CFIA) that gives authority to the Veterinary Biologics Section (VBS) of the Animal Health and Production Division (AHPD) approved the IHNV DNA vaccine for commercial use in Canada in 2005 [ 94 ]. Five aspects were taken into consideration before the vaccine was approved: (i) public perception and acceptance, (ii) regulatory and environmental concerns, (iii) risk-benefit, (iv) feasibility of producing the vaccine at a scale and cost appropriate for the fish industry, and (v) intellectual property issues [ 91 ]. At present there has not been approved any DNA vaccine to be used in aquaculture in Europe.…”

Nanotechnology applied to European food production – A review of ethical and regulatory issues

“…when animals are marketed (Nguyen, Ngo, & Nguyen, 2012). The Promotes an integrated, safe and responsible approach to use of nanotechnology and ensures that applications and use of nanosciences and nanotechnologies comply with the high level of public health, safety, consumer and worker protection, and environmental protection encapsulated vaccine is released into the water but only released from the micro-capsule once ingested by the fish (Nielsen, Fredriksen, & Myhr, 2011). Research on the nano-modification of seeds (precision GM) has the potential to enable very precise genetic modification of seeds (Scrinis and Lyons, 2007), and could potentially be extended to animals.…”