The regulations necessary to implement the Precision Breeding Act 2023 for plants in England has now been laid in Parliament and will be voted through in both Houses.
The Act will come into force six months later, accompanied by technical guidance for applicants from Defra and the FSA (Food Stndards Agency).
This means the regulatory process enabling Precision Bred Organism to be authorised for use in farming and food production should be open to seed breeding and technology companies from early autumn 2025, less than five years after the government first launched a broad consultation on a new regulatory approach for genetic technologies.
Given the complex and contentious nature of the topic, and the change of government, this timescale is a really significant achievement.
NFU position
The NFU continues to be closely engaged, attending stakeholder sessions to go through the secondary legislation, and to discuss industry-led approaches to co-existence between precision-bred and organic crops and supply chains.
As the Organics Regulations will not be updated to align with the new legislation, for this sector PBOs (precision-bred organisms) remain defined as GMOs (genetically modified organisms) and are therefore not allowed.
We are exploring the degree to which existing traceability, segregation and separation measures will enable organic producers to avoid PB inputs.
The Precision Breeding Industry Working Group, which is Ministerially appointed, has been reinstated with the goal to explore and facilitate routes to market and explore issues such as the internal market given the legislation is currently England only.
Secondary legislation to implement the farmed animals element of the Precision Breeding Act is still needed, with welfare assessment the main element yet to be fully developed.
Seeds regulation
Defra recently launched a consultation on a proposed Plant Varieties and Seeds Framework including an England-only National List for precision-bred varieties of crop plants.
It wants to know what varieties information businesses and other organisations would find beneficial, and what impact the possible mandatory inclusion of precision-bred status on existing official seed labels would have in addition to other available sources of information, such as industry-led PB plant variety registers, existing industry lists of recommended varieties, and the official Plant Varieties and Seeds Gazette.
Plant Breeders’ Rights processes are not being changed.
Under the terms of the UK Internal Market Act, the consultation also makes clear that while the seed of precision-bred varieties can legally be sold into Scotland and Wales, it would have to be regulated under devolved GMO regulations to be cultivated or harvested.
European Union
The EU is also trying to achieve legislative reform to regulate new genomic techniques such as gene editing, NGTs (new genomic techniques), in plants differently to GMOs
The Polish Presidency has shown remarkable determination in making progress and its current draft text aimed to address patents, for products and processes, a key area of blockage in negotiations.
There finally seems to be support from enough Council working party members to move the process forward. Progress in the EU may enable UK devolved administrations to view the Precision Breeding Act more positively, given their concerns about diverging with the EU on regulating NGTs.
The EFSA (European Food Safety Authority) has released a draft opinion on the use of NGTs in animals, now open for public consultation.
It concludes no novel hazards or risks from the NGT process or trait compared to conventional breeding, and the need to align assessments of all breeding techniques with the latest welfare science.
The NFU attended a webinar where EFSA presented its analysis and evidence and will respond to the consultation through BAB (British Agriculture Bureau).
