Removing politics from innovations that improve food security.

Genetically modified (GM) organisms and crops have been a feature of food production for over 30 years. Despite extensive science-based risk assessment, the public and many politicians remain concerned with the genetic manipulation of crops, particularly food crops. Many governments have addressed public concern through biosafety legislation and regulatory frameworks that identify and regulate risks to ensure human health and environmental safety. These domestic regulatory frameworks align to international scientific risk assessment methodologies on a case-by-case basis. Regulatory agencies in 70 countries around the world have conducted in excess of 4400 risk assessments, all reaching the same conclusion: GM crops and foods that have been assessed provide no greater risk to human health or the environment than non-GM crops and foods. Yet, while the science regarding the safety of GM crops and food appears conclusive and societal benefits have been globally demonstrated, the use of innovative products have only contributed minimal improvements to global food security. Regrettably, politically-motivated regulatory barriers are currently being implemented with the next genomic innovation, genome editing, the implications of which are also discussed in this article. A decade of reduced global food insecurity was witnessed from 2005 to 2015, but regrettably, the figure has subsequently risen. Why is this the case? Reasons have been attributed to climate variability, biotic and abiotic stresses, lack of access to innovative technologies and political interference in decision making processes. This commentary highlights how political interference in the regulatory approval process of GM crops is adversely affecting the adoption of innovative, yield enhancing crop varieties, thereby limiting food security opportunities in food insecure economies.

Regulatory approaches for genome edited agricultural plants in select countries and jurisdictions around the world.

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.

Report on the SCRA Nuts and Bolts Workshop II: case studies of citrus greening, Ultra-low Gossypol Cotton, and blight tolerant, low-acrylamide potato.

To be commercialized and grown in the US, genetically engineered (GE) crops typically go through an extensive food, feed, and environmental safety assessment process which, in certain instances, requires complex consultations with three different US regulatory agencies. Many small market, niche, and specialty crops have been genetically engineered using the modern tools of recombinant DNA but few have been commercialized due to real or perceived regulatory constraints. This workshop discussed the practical aspects of developing dossiers on GE specialty, niche, or small-market crops/products for submission to US regulatory agencies. This workshop focused on actual case studies, and provided an opportunity for public or private sector scientists and crop developers to spend time with regulatory officials to learn the specifics of compiling a dossier for regulatory approval. The objective of the workshop was to explain and demystify data requirements and regulatory dossier compilation by small companies, academics, and other developers.

Rebuttal to Commentary of Prof Yilmaz.

In his commentary on winning public and political regulatory support for safe agricultural products derived from biotechnology, Prof Yilmaz invokes Aesop's fable, posing a metaphorical pro-science tortoise racing against an anti-science hare, concluding that the role of the slow tortoise is the preferred one, as the chelonian, backed by science, plods along to ultimately win the race. If only life were a fairy tale. In countering Prof Yilmaz's conclusion, I'm happy to adopt his tortoise and hare metaphor in illustrating the problems the agbiotech communities, both private and public, industry and academic, encountered in real life.

A critical assessment of regulatory triggers for products of biotechnology: Product vs. process.

Regulatory policies governing the safety of genetic engineering (rDNA) and the resulting products (GMOs) have been contentious and divisive, especially in agricultural applications of the technologies. These tensions led to vastly different approaches to safety regulation in different jurisdictions, even though the intent of regulations-to assure public and environmental safety-are common worldwide, and even though the international scientific communities agree on the basic principles of risk assessment and risk management. So great are the political divisions that jurisdictions cannot even agree on the appropriate triggers for regulatory capture, whether product or process. This paper reviews the historical policy and scientific implications of agricultural biotechnology regulatory approaches taken by the European Union, USA and Canada, using their respective statutes and regulations, and then critically assesses the scientific underpinnings of each.

Genome editing for crop improvement: Challenges and opportunities.

Genome or gene editing includes several new techniques to help scientists precisely modify genome sequences. The techniques also enables us to alter the regulation of gene expression patterns in a pre-determined region and facilitates novel insights into the functional genomics of an organism. Emergence of genome editing has brought considerable excitement especially among agricultural scientists because of its simplicity, precision and power as it offers new opportunities to develop improved crop varieties with clear-cut addition of valuable traits or removal of undesirable traits. Research is underway to improve crop varieties with higher yields, strengthen stress tolerance, disease and pest resistance, decrease input costs, and increase nutritional value. Genome editing encompasses a wide variety of tools using either a site-specific recombinase (SSR) or a site-specific nuclease (SSN) system. Both systems require recognition of a known sequence. The SSN system generates single or double strand DNA breaks and activates endogenous DNA repair pathways. SSR technology, such as Cre/loxP and Flp/FRT mediated systems, are able to knockdown or knock-in genes in the genome of eukaryotes, depending on the orientation of the specific sites (loxP, FLP, etc.) flanking the target site. There are 4 main classes of SSN developed to cleave genomic sequences, mega-nucleases (homing endonuclease), zinc finger nucleases (ZFNs), transcriptional activator-like effector nucleases (TALENs), and the CRISPR/Cas nuclease system (clustered regularly interspaced short palindromic repeat/CRISPR-associated protein). The recombinase mediated genome engineering depends on recombinase (sub-) family and target-site and induces high frequencies of homologous recombination. Improving crops with gene editing provides a range of options: by altering only a few nucleotides from billions found in the genomes of living cells, altering the full allele or by inserting a new gene in a targeted region of the genome. Due to its precision, gene editing is more precise than either conventional crop breeding methods or standard genetic engineering methods. Thus this technology is a very powerful tool that can be used toward securing the world's food supply. In addition to improving the nutritional value of crops, it is the most effective way to produce crops that can resist pests and thrive in tough climates. There are 3 types of modifications produced by genome editing; Type I includes altering a few nucleotides, Type II involves replacing an allele with a pre-existing one and Type III allows for the insertion of new gene(s) in predetermined regions in the genome. Because most genome-editing techniques can leave behind traces of DNA alterations evident in a small number of nucleotides, crops created through gene editing could avoid the stringent regulation procedures commonly associated with GM crop development. For this reason many scientists believe plants improved with the more precise gene editing techniques will be more acceptable to the public than transgenic plants. With genome editing comes the promise of new crops being developed more rapidly with a very low risk of off-target effects. It can be performed in any laboratory with any crop, even those that have complex genomes and are not easily bred using conventional methods.

GM crops and foods: what do consumers want to know?

Agricultural biotechnology--GMOs--has a huge positive impact on farming and farmers but remains controversial among the skeptical public. Curious but anxious consumers, driven by scare stories and pseudo-science provided by anti-GMO activists, seek accurate and authoritative answers to their questions. Here, I address a sample of such queries directed to me from the public, including the ubiquitous "Is it safe?" and also discuss some of the shameful tactics used by anti-GM activists in the public debate to garner support at the cost of inciting unnecessary anxiety among the public.

Popular misconceptions: agricultural biotechnology.

Agricultural biotechnology, especially genetic engineering or genetic modification (GM), is a topic of considerable controversy worldwide. The public debate is fraught with polarized views and opinions, some are held with religious zeal. Unfortunately, it is also marked with much ignorance and misinformation. Here we explore some popular misconceptions encountered in the public debate.

Regulating innovative crop technologies in Canada: the case of regulating genetically modified crops.

The advent of genetically modified crops in the late 1980s triggered a regulatory response to the relatively new field of plant genetic engineering. Over a 7-year period, a new regulatory framework was created, based on scientific principles that focused on risk mitigation. The process was transparent and deliberately sought the input of those involved in crop development from non-governmental organizations, industry, academia and federal research laboratories. The resulting regulations have now been in place for over a decade, and the resilience of the risk-mitigating regulations is evident as there has been no documented case of damage to either environment or human health.

US regulatory system for genetically modified [genetically modified organism (GMO), rDNA or transgenic] crop cultivars.

This 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.

Public perceptions of biotechnology.

The very term 'Biotechnology' elicits a range of emotions, from wonder and awe to downright fear and hostility. This is especially true among non-scientists, particularly in respect of agricultural and food biotechnology. These emotions indicate just how poorly understood agricultural biotechnology is and the need for accurate, dispassionate information in the public sphere to allow a rational public debate on the actual, as opposed to the perceived, risks and benefits of agricultural biotechnology. This review considers first the current state of public knowledge on agricultural biotechnology, and then explores some of the popular misperceptions and logical inconsistencies in both Europe and North America. I then consider the problem of widespread scientific illiteracy, and the role of the popular media in instilling and perpetuating misperceptions. The impact of inappropriate efforts to provide 'balance' in a news story, and of belief systems and faith also impinges on public scientific illiteracy. Getting away from the abstract, we explore a more concrete example of the contrasting approach to agricultural biotechnology adoption between Europe and North America, in considering divergent approaches to enabling coexistence in farming practices. I then question who benefits from agricultural biotechnology. Is it only the big companies, or is it society at large--and the environment--also deriving some benefit? Finally, a crucial aspect in such a technologically complex issue, ordinary and intelligent non-scientifically trained consumers cannot be expected to learn the intricacies of the technology to enable a personal choice to support or reject biotechnology products. The only reasonable and pragmatic alternative is to place trust in someone to provide honest advice. But who, working in the public interest, is best suited to provide informed and accessible, but objective, advice to wary consumers?