The proposal is expected to exclude a new generation of GMOs from risk assessment and transparency requirements. Whether the Commission will present it on the 7th of June 2023, as announced, is not clarified yet.
Meanwhile England (not the UK) has removed new GMOs from the regulatory system for GMOs. The Genetic Technology (the so-called Precision Breeding) Bill received Royal Assent on 23rd of March 2023.
Seven EU environment ministers challenge Commission’s upcoming proposal to deregulate new GMOs
The debate at the Council meeting was initiated by the Austrian environment minister Leonore Gewessler. In her speech she insisted on the need for consumer labelling and proposed to set up an ad hoc Council working group to enable a comprehensive discussion on new GMOs including the environment, health, and agriculture ministries.
Austria, Cyprus, Hungary, Luxembourg, and Slovakia criticized the European Commission’s proposal for eroding safety checks for new GMOs. Austria, Cyprus, Hungary, and Slovenia called for the upcoming discussions at EU Council level to involve environment, health, and agriculture ministries, to ensure that all aspects linked to GMOs are reflected in the legislation. More research on how biodiversity could be harmed using new GMOs was called for by Austria, Cyprus, Luxembourg, and Slovenia and strict labelling requirements to be upheld for new GMOs to ensure transparency for consumers were demanded by Germany and Luxembourg.
England’s bill on so-called precision breeding adopted
Outside the EU and the EU’s rules on GMOs, England has adopted a new legislative framework for plants and vertebrate animals (excluding humans) made with New Genomic Techniques such as CRISPR/Cas. The Genetic Technology (so-called Precision Breeding) Bill does not regulate new GMOs as GMOs any more. Instead, it has created a new class of GMOs, so-called precision-bred organisms (PBOs). They are defined as organisms whose genomes could have resulted from traditional processes or natural transformation. PBOs are excluded from mandatory risk assessment, traceability and labelling. The bill is not limited to agriculture, it applies also to wildlife plants and animals, as well as to pets and other non-agriculture animals.
How is the deregulation of PBOs – i.e. the abolition of safety and transparency standards for new GMOs – justified? The English lawmakers have put conventional breeding, processes that happen in nature and new genomic techniques on the same level. The bill aims to treat supposedly equal things equally; if plants and animals produced with conventional breeding methods or ones which could occur naturally do not have to be risk assessed or labelled as GMOs, then consequently plants and animals made with NGTs do not have to either. The term PBO (and the deregulation policy behind it) have been questioned in an open letter by more than 100 scientists and policy experts as technically and scientifically inaccurate and misleading.
Hardly any transparency – and ongoing legislative process
The bill provides a register for PBOs released into the environment and/or the food and feed supply. But it is not clear how much information will be available on the PBOs and how the access to information will be regulated. And even if such a register can serve as a starting point for traceability – the bill does not foresee information for business operators and consumers about the PBO status of a product.
The grant of the Royal Assent on the 23rd of March 2023 is not the end of the legislative process: To make the law “operational” about 30 pieces of secondary legislation have to pass, which could take another 18-24 months.
Conflicts in the UK
Neither the Scottish nor Welsh Parliaments have granted legislative consent to the Bill. The Scottish and Welsh Governments have indicated they do not plan to change regulation of GE technologies for food and feed. The Scottish Government said it would block the application of this bill in Scotland.
But due to the UK Internal Market Scotland and Wales cannot stop sales of any PBOs or products made from them that have been approved in England. Regarding commercial cultivation, it is a widespread assumption that Scotland and Wales can stop PBOs in their countries as agriculture lies in their responsibility. Meanwhile experimental releases will take place in England, without safety and anti-contamination measures. It is expected that it will be at least five years before new GMOs for commercial cultivation could be available for farmers in England.
Distortions of English and EU markets?
Currently English PBOs are GMOs in the EU and subject to EU GMO legislation. They need to be authorised to enter EU markets, otherwise they are illegal.
Whether this will lead to future market distortions depends on what the future EU legislation for new GMOs will look like. (An important difference between England and the EU: The EU only deals with GM plants, not with animals.) One of the options for a possible deregulation presented by the EU Commission - the most far-reaching one - is nearly identical to the approach taken in the English bill. Option 4 proposes the abolition of a risk assessment for plants obtained by NGTs that could occur naturally or be produced by conventional breeding. Whether there will be any transparency requirements for these allegedly ‘breeding like’ or ‘nature like’ new GMOs is an open question.
Should the EU use the English bill as a blueprint and deregulate new GMOs to the maximum there will be hardly any market distortions. Should the EU keep its high food safety and transparency standards for new GMOs (as ENGA and the EU food/retail sector advocates for), then UK food exporters (due to the UK Internal market) can expect difficult times ahead.