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Professor Huw Jones04 May 2016 at 16:10
The Government statement is sound and the final sentence is particularly important. Progress in genomics is underpinning far-reaching changes in plant and animal breeding methodologies including the use of precise in-vitro biotechnological processes to introduce novel variation by editing the existing genome. To achieve necessary levels of safety, consumer confidence and technological innovation, proportionate and risk-based regulatory oversight of these new biotechnologies is vital. However, the solution should be more nuanced than a binary in/out trigger based on current definitions of a GMO. For example, novel foods legislation or varietal registration rules could be adapted to accommodate some products of molecular breeding. Products that pose no additional risks to human or animal health may need no pre-market risk assessment at all, but could be monitored, post-commercialisation, for environmental effects that would be difficult to analyse pre-market. Finally, because many crops are traded globally, our regulatory expectations should be internationally adaptable.
Professor Andrew Webster, Co-Chair AsSIST-UK20 April 2016 at 09:37
In responding to this opportunity to comment on the Government’s overview relating to GM groups, a key issue is that if, as many GM scientists seek, the EU and MS press for a national oversight of GMOS (as happens in pharmaceuticals in the UK via the MHRA or FDA in the US) there needs to be a robust approvals process, especially if, as most GMO scientists want, this is done on a product-by-product basis. The main point here then would be on what basis would a new product be judged: would it be simply in terms of safety and efficacy? There have been calls for pharmaceutical products to be assessed not simply on this basis as the industry prefers, but how they compare with best existing therapies – an approach that the drugs industry resists (relying on the cheaper and easier placebo-controlled study). In the context of GMO regulation, similar questions can be raised about comparators and more generally, as in the case of the relation between pharmaceutical and health, the relation between high-tech agriculture and the wider food production and supply system and the contribution a new product can make within that wider context. These are not formal ‘regulatory’ issues but do raise issues about the sustainability of food systems. Basically, the current EU/UK provisions make sense when defined in terms of the scientific evidence for safety etc, and in terms of the ‘evidence check’ they concur with much of the scientific literature. But all technological systems – here agribiotech – need to acknowledge uncertainties – for example, the possibility of the unintended transfer of antibiotic-resistance genes at a time when the issue of AMR is high on the policy agenda, or, relatedly, whether the extensive use of herbicide and insect resistant crops could result in the emergence of resistant weeds and insects. So, as the considerable body of ESRC-funded research in social science shows, there is a need to recognise that any decisions need to be taken under some conditions of ignorance. These can be risk-assessed and so quantified, but beyond such calculations we would need to ensure – as in the case of the MHRA for drugs approvals – a strong and transparent process is put in place. This will become even more important if the UK votes to leave the EU. Finally, risk-based policy may make sense but we know that it cannot cope with the range of contingencies that happen in the ‘real world’ or the inevitable appearance of unforeseen events.
Alice Foxall07 April 2016 at 18:34
I agree with the government's diagnosis on the GM and gene editing evidence: that it has been scientifically proven to be safe. I disagree with the EU regulation on regulation of GM organisms. The EU regulate GM organisms on the process in which they are created, this regulation process is contrasting to those in place of many other countries, such as Canada which regulates based on traits introduced or Japan which works on a case-by-case basis. The EU regulation means that all crops using one technology are either banned or legal. For example, chemical mutagenesis is legal and other forms of GM are illegal. I agree that the GM crop issue is not just a scientific issue, if it was, it would be made legal. I agree that there are also social, political and economic issues. This is why I believe that regulation should be either trait based or on a case-by-case basis, the current regulation process means that many crops that could have a good benefit to society are banned. A lot of companies have used scaremongering of GM in the past, the scientific evidence is there, and I would like to see the evidence that GM is just for the profit of big companies, as suggested on the comments previously. A lot of people are still against GM technologies that are 30 years old, new technologies such as CRISPR and other gene editing technologies are being developed and are very promising, and it would be a shame for all gene edited crops to be banned in the same way that other GM technologies have been.
catherine meads07 April 2016 at 17:27
I cannot see how anyone would know if a GM crop caused harm because studies investigating harm to humans would need to have suitable comparators, and that is not possible in the case of a GM crop because humans eat such a wide range of foods and quite a few foods now will be GM. To prevent a human from not eating GM food, one would need to lock them away and provide all their food for a number of years. Obviously ethically this is not possible and even if it was possible, it would not be that good as a comparison because of all of the other factors involved in controlling people's food for years. Even if properly controlled studies had been conducted at the start of GM crop development, they would have been contaminated during the follow up by now because of GM food being mixed in with non-GM food in people's diets. Therefore the policy is based on opinion rather than evidence and we all know that opinions can be wildly wrong.
Roland Jackson04 April 2016 at 12:33
The Government’s statement on GM and Gene Editing exemplifies precisely why there is such difficulty in making policy that will stick in this area. It starts from the implicit assumption that the only salient question, on which evidence is to be sought, relates to safety (to humans and the environment, however those are to be defined). This is clearly not the case, as the submission from Rowan Alcock below illustrates. So, a problem both for this ‘evidence check’ and for evidence checks in general, is that others may define the important questions and issues differently from Government, and that the answers to those may be critical in terms of defining political and practical feasibility. It is worth asking, then: What is the range of questions on which evidence needs to be sought (and who is asking the questions)? What sort of evidence in each case would be most appropriate and, crucially, would be seen as valid by significant stakeholders (not just by Government)? In this statement the Government makes a strong play for decisions to be ‘science-based’. Clearly they should be ‘science-informed’, but by what science, providing evidence to what questions? And to inform what decisions? The statement concentrates on questions of regulation, yet many of the issues raised by GM and Gene Editing are much wider, as they are to do with choices about alternatives, and models of agriculture and trade, as much as about safety. To ignore these questions, and seek to load them all onto the process of regulatory approval on safety grounds, which seems to be the Government’s current position, is to invite political opposition. Hence the contested nature of regulatory approval in Europe; there is no other obvious forum for the wider debates to be had. The development of technologies is as much a social, political and economic process as a scientific one, so evidence required to make sound policy decisions around questions of GM and Gene Editing should include a much wider framing of the important questions, and a much wider range of evidence, from the social, political and economic sciences as well as the biological and ecological sciences.
Rowan Alcock29 March 2016 at 18:26
The scientific evidence suggests GM crops are safe to consume however evidence from the UN and organisations working on small scale farms in Africa, Asia and India suggests GM is not the right political, social, economic or environmental solution to feeding the world. A large body of evidence suggests monoculture which GM often promotes is bad for the environment, that oligopolies of seed and pesticide companies which GM tends towards is bad for the farmer and consumer economically, that GM companies lobbying government is democratically questionable, that agroeconomic methods can sequester 100% of man-made carbon emissions if done world wide to high standards, that GM threatens traditional small scale farming practice in developing countries, that super weeds are a problem in GM cultivation, that biodiversity is not promoted in GM farming and that consumers are wary of GM food. Reducing global food waste, reducing world meat consumption, working with small scale farmers using low tech agroecological methods and investing in scientific research on agroecology is likely to be the best way to feed the world in the future, although of course this won't create profits for multinational corporations in the same way as GM will. In sum there is a large body of evidence that suggests GM is the wrong solution to feed the world and it is clear the main factor in the promotion of GM is profit.