The Role of Alternative Testing Strategies in Environmental Risk Assessment of Engineered Nanomaterials

Within toxicology there is a pressure to find new test systems to replace, reduce and refine animal testing. In nanoecotoxicology this raises a number of questions

Parameters, practices, and preferences for regulatory review of emerging biotechnology products in food and agriculture

This paper evaluates the U.S. regulatory review of three emerging biotechnology products according to parameters, practices, and endpoints of assessments that are important to stakeholders and publics. First, we present a summary of the literature on variables that are important to non-expert publics in governing biotech products, including ethical, social, policy process, and risk and benefit parameters. Second, we draw from our USDA-funded project results that surveyed stakeholders with subject matter expertise about their attitudes towards important risk, benefit, sustainability, and societal impact parameters for assessing novel agrifood technologies, including biotech. Third, we evaluate the regulatory assessments of three food and agricultural biotechnology case studies that have been reviewed under U.S. regulatory agencies and laws of the Coordinated Framework for the Regulation of Biotechnology, including gene-edited soybeans, beef cattle, and mustard greens. Evaluation of the regulatory review process was based on parameters identified in steps 1 and 2 which were deemed important to both publics and stakeholders. Based on this review, we then propose several policy options for U.S. federal agencies to strengthen their oversight processes to better align with a broader range of parameters to support sustainable agrifood products that rely on novel technologies. These policy options include 1) those that would not require new institutions or legal foundations (such as conducting Environmental Impact Statements and/or requiring a minimal level of safety data), 2) those that would require a novel institutional or cross-institutional framework (such as developing a publicly-available website and/or performing holistic sustainability assessments), and 3) those that would require the agencies to have additional legal authorities (such as requiring agencies to review biotech products according to a minimal set of health, environmental, and socio-economic parameters). Overall, the results of this analysis will be important for guiding policy practice and formulation in the regulatory assessment of emerging biotechnology products that challenge existing legal and institutional frameworks

Redefining risk research priorities for nanomaterials

Chemical-based risk assessment underpins the current approach to responsible development of nanomaterials (NM). It is now recognised, however, that this process may take decades, leaving decision makers with little support in the near term. Despite this, current and near future research efforts are largely directed at establishing (eco)toxicological and exposure data for NM, and comparatively little research has been undertaken on tools or approaches that may facilitate near-term decisions, some of which we briefly outline in this analysis. We propose a reprioritisation of NM risk research efforts to redress this imbalance, including the development of more adaptive risk governance frameworks, alternative/complementary tools to risk assessment, and health and environment surveillance

Fostering Responsible Innovation through Stakeholder Engagement: Case Study of North Carolina Sweetpotato Stakeholders

Stakeholder and community engagement are critical for the successful development of new technologies that aim to be integrated into sustainable agriculture systems. This study reports on an approach used to engage stakeholders within the sweetpotato community in North Carolina to understand their preferences, needs, and concerns as they relate to a new sensing and diagnostic platform. This work also demonstrates an example of real-time technology assessment that also fosters responsible innovation through inclusivity and responsiveness. Through the conduction of 29 interviews with sweetpotato stakeholders in North Carolina, we found that participants found the most value in detecting external sweetpotato characteristics, as well as the ability to use or connect to a smartphone that can be used in field. They also found value in including environmental parameters and having a Spanish language module. Most participants indicated that they were comfortable with sharing data as long as it benefited the greater North Carolina sweetpotato industry, and were concerned with sharing these data with “outside” competitors. We also observed differences and variations between stakeholder groups. Overall, this work demonstrates a relatively simple, low-cost approach to eliciting stakeholder needs within a local agricultural context to improve sustainability, an approach that could be leveraged and transferred to other local agrifood systems