SummaryThis paper reviews the history of the federal regulatory oversight of plant agricultural biotechnology in the USA, focusing on the scientific and political forces moulding the continually evolving regulatory structure in place today. Unlike most other jurisdictions, the USA decided to adapt pre-existing legislation to encompass products of biotechnology. In so doing, it established an overarching committee (Office of Science and Technology Policy) to study and distribute various regulatory responsibilities amongst relevant agencies: the Food and Drug Administration, Environmental Protection Agency and US Department of Agriculture. This paper reviews the history and procedures of each agency in the execution of its regulatory duties and investigates the advantages and disadvantages of the US regulatory strategy.

Summary A special regulatory regime applies to products of recombinant nucleic acid modifications. A ruling from the European Court of Justice has interpreted this regulatory regime in a way that it also applies to emerging mutagenesis techniques. Elsewhere regulatory progress is also ongoing. In 2015, Argentina launched a regulatory framework, followed by Chile in 2017 and recently Brazil and Colombia. In March 2018, the USDA announced that it will not regulate genome‐edited plants differently if they could have also been developed through traditional breeding. Canada has an altogether different approach with their Plants with Novel Traits regulations. Australia is currently reviewing its Gene Technology Act. This article illustrates the deviation of the European Union's (EU's) approach from the one of most of the other countries studied here. Whereas the EU does not implement a case‐by‐case approach, this approach is taken by several other jurisdictions. Also, the EU court ruling adheres to a process‐based approach while most other countries have a stronger emphasis on the regulation of the resulting product. It is concluded that, unless a functioning identity preservation system for products of directed mutagenesis can be established, the deviation results in a risk of asynchronous approvals and disruptions in international trade.

Genome editing in agriculture and food is leading to new, improved crops and other products. Depending on the regulatory approach taken in each country or region, commercialization of these crops and products may or may not require approval from the respective regulatory authorities. This paper describes the regulatory landscape governing genome edited agriculture and food products in a selection of countries and regions.

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The plasma of patients with overt variegate porphyria contains porphyrin with a fluorescence emission maximum at about 626 nm, which is diagnostic for the condition. We have evaluated qualitative fluorescence emission scanning of saline-diluted plasma as a method for the identification of asymptomatic carriers of the gene for variegate porphyria. Plasma from 36 unrelated patients with variegate porphyria, 136 of their asymptomatic first- and second-degree relatives aged 15 years or over, and 322 normal subjects was scanned. An emission maximum between 621 and 627 nm was observed in the 36 patients with variegate porphyria and 54 of their relatives, but not in any normal subject, nor in 56 patients with other types of porphyria. For the detection of asymptomatic adult carriers of the gene for variegate porphyria, fluorescence emission scanning of plasma appears to be 100% specific, with a sensitivity of 86% (95% confidence interval 71-98%). In contrast, the sensitivity of faecal porphyrin analysis as a test for adult gene carriers was 36%. These results suggest that fluorescence emission scanning of plasma should replace faecal porphyrin analysis as the test of first choice for this purpose.

Innovation in agriculture is pervasive. However, in spite of the success stories of twentieth century plant breeding, the twenty-first century has ushered in a set of challenges that solutions from the past century are unlikely to address. However, sustained research and the amalgamation of a number of disciplines has resulted in new breeding techniques (NBTs), such as genome editing, which offer the promise of new opportunities to resolve some of the issues. Here we present the results of an expert survey on the added potential benefits of genome-edited crops compared to those developed through genetic modification (GM) and conventional breeding. Overall, survey results reveal a consensus among experts on the enhanced agronomic performance and product quality of genome-edited crops over alternatives. The majority of experts indicated that the regulations for health and safety, followed by export markets, consumers, and the media play a major role in determining where and how NBTs, including genome editing, will be developed and used in agriculture. Further research is needed to gauge expert opinion after the Court of Justice of the European Union ruling establishing that site-specific mutagenic breeding technologies are to be regulated in the same fashion as GM crops, regardless of whether foreign DNA is present in the final variety. Electronic supplementary material The online version of this article (10.1007/s11248-019-00118-5) contains supplementary material, which is available to authorized users.

Phenomics or automated phenotyping (AP) is an emerging approach, identified as a priority for future crop breeding research. This approach promises to provide accurate, precise, fast, large-scale, and accumulated phenotyping data which when integrated with corresponding genomic and environmental data is expected to trigger a great leap forward in plant breeding. However, despite promising applications, AP adoption in plant breeding is still in its infancy. It is unclear to many plant breeders how or if much of the enormous volume, diversity, and velocity of imaging and remote-sensing data generated by AP is going to be usefully integrated into breeding programs. This paper develops an economical model of heterogeneous breeders' decisionmaking to examine adoption decisions regarding whether to adopt AP or continue using conventional phenotyping. The results of this model indicate that many interlocking factors, including genetic gain/expected return, variable and sunk costs, subsequent rate of technology improvement, and breeders' level of aversion to AP, are at work as breeders determine whether to adopt AP. This study also provides a numerical example to show the impact of breeders' aversion toward the adoption of a new technology (e.g., AP) on the expected return generated from breeding a new wheat variety.