User:Nick Moyes/sandbox/NBT


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New Breeding Techniques (NBT), also named New Genetic Engineering Techniques, is a term that encompasses a suite of genetic engineering methods that could increase and accelerate the development of new traits in plant breeding. These new techniques, often involve 'genome editing' whose intention is to modify DNA at specific locations within the plants' genes so that new traits and properties are produced in foodplants.

From the early 200s there has been increasing concern and debate in many parts of the world, especially as to whether NBTs should be included within the same pre-existing governmental regulations to control genetic modification,   and accusations that biotechnology companies have cynically devised a special name for these new processes intentionally to circumvent existing legislation relevant to genetically modified organism s (GMOs).

Methods involved
New breeding techniques (NBTs) make specific changes within plant DNA in order to change its traits, and these modifications can vary in scale from altering single base, to inserting or removing one or more genes. The various methods of achieving these changes in traits include the following:
 * Cutting and modifying the genome during the repair process (three tools are used to achieve this: Zinc finger nuclease; TALENs, and CRISPR/Cas Tools)
 * Genome editing to introduce changes to just a few base pairs (using a technique called 'oligonucleotide-directed mutagenesis' (ODM)).
 * Transferring a gene from an identical or closely-related species (cisgenesis)
 * Adding in a reshuffled set of regulatory instructions from same species (intragenesis)
 * Deploying processes that alter gene activity without altering the DNA itself (epigenetic methods)
 * Grafting of unaltered plant onto a genetically modified rootstock

Distinction from genetic modification
The subtle and very specific actions of new breeding techniques are different from previously understood processes involved in genetic engineering, as they result in there being no foreign DNA in the newly-created organism, and thus plants with new traits are indistinguishable from those bred by conventional plant breeding methods.

Various concerns have been raised over the uncontrolled introduction of new breeding techniques, especially with regard the ability of research companies to patent crops whose traits they have developed by these techniques and thus for large companies to have power and control of an entire food chain.

One major issue that concerns many NGOs is the suspicion that efforts to promote new breeding techniques as a concept are very specifically intended to circumvent existing regulatory processes for genetically modified organisms (GMOs), and that they fall outside some countries' legal definition of GMOs.

Potential benefits and disbenefits
Critics of biotechnology and genetic modification have called NBTs “hidden GMOs” and an example of “extreme engineering”. Many are calling for new breeding techniques to be regulated, just like any other genetically modified organism. In contrast, supporters of biotechnology supporters assert that regulating them like all other GMOs would stiffle innovation and food development.

In the UK, the National Farmers' Union has welcomed NBTs, pointing out they deliver characteristics that every plant breeder aspires to, namely increased yields, disease and pest resistance and tolerance to climatic change. They also have the potential to reduce the cost and time of bringing and plants with desirable new traits from laboratory to market, as well as reducing the number of unwanted traits that might otherwise have been accidentally introduced during traditional plant breeding processes. Other benefits that have been identified include the ability to enhance nutrient content, appearance, flavour or texture.

Many European environmental organisations came together in 2016 to jointly express serious concerns over new breeding techniques.

Regulatory concerns
New breeding techniques (NBTs) as a collective term may allow biotechnology companies to circumvent existing regulatory processes regarding genetically modified organisms (GMOs), as these were originally designed to apply to organisms containing genes from other species. The regulation of food products derived from NBTs in countires around the world varies greatly (as at 2017), from non-existent to in-place. The rapid pace of technological developments has left many governments scrambling to keep up with them and to decide whether or how to regulate them.

OECD
The Organization for Economic Cooperation and Development (OECD) has its own 'Working Group on Harmonization of Regulatory Oversight in Biotechnology' but, as at 2015, there had been virtually no progress in addressing issues around NBTs, and this includes many major food-producing countries like Russia, South Africa, Brazil, Peru, Mexico, China, Japan and India. Despite its huge potential importance for trade and agriculture, as well as potential risks, the majority of food producing countries in the world at that date still had no policies or protocols for regulating or analysing food products derived specifically from new breeding techniques.

South America
Argentina is regarded as one of the leaders in GMO regulation, and was the first country in the world to debate and then specifically introduce regulations and protocols affecting NBTs. These were in place by 2015 and gave clarity to plant developers at an early stage so they could anticipate whether or not their products were likely to be regarded as GMOs. The protocols conform to the internationally recognised 2003 Cartagena Protocol on Biosafety.

US
The United States Department of Agriculture is responsible for determining whether food products derived from NBTs should be regulated, and this is undertaken on a case-by-case manner under the US Plant Protection Act. As of 2015 there was no specific policy towards NBTs, although in the summer of that year the White House announced plans to update the U.S. Regulatory Framework for Biotechnology. This is likely to be of significant commercial relevance, as the US is a major producer and exporter of food products which have been genetically modified; NBT-derived foods may well be included within those exports in the near future.

Canada
Canada's food regulatory system differs from those of most other countries, and its procedures already accommodate products from any breeding technique, including NBTs. This is because its 1993 'Biotechnology Regulatory Framework' is based upon a concept of regulatory triggering based upon "Plants with Novel Traits". In other words, if a new trait does not exist within normal cultivated plant populations in Canada, then no matter how it was developed, it will trigger the normal regulatory processes and testing.

European Union
In Europe, a list of seven new breeding techniques were presented before the European Commission in 2015 for it to decide whether or not the products of these processes (which are sometimes used in combination with one another) fall inside or outside of existing EU laws on genetically modified organisms. The European Commission subsequently announced that its long-anticipated ruling would not be made until an EU Court of Justice ruling on a related matter had taken place sometime in 2018. This led to concerns that food and biotech companies would have a backdoor through which these new forms of 'genetically modified organisms' would be planted and spread across EU farmland, and that the resulting food products would be subject to no risk-assessment, montoring or labelling, and that citizens of the EU would be unaware these plants were even being grown.

Australia and New Zealand
As at December 2017, Food Standards Australia New Zealand (FSANZ) was undertaking a review of the two country's Food Standards Code with respect to how it applies to food originating from new breeding techniques. Scheduled for completion by mid-2018, the review considers how its 20 year-old standard for "Food produced using gene technology" (Standard 1.5.2) is applicable to these new techniques which were not then available, and to what extent any food products originating from NBTs should be sampled and tested prior to market release. The review also considers whether its definition of gene technology (used in Standard 1.1.2─2) needs to be amended to ensure there is clarity over which food products will require pre-market approval.

Random mutations
Gene editing techniques such zinc finger nucleases as CRISPR are accompanied by the risk of detrimental off-target mutations.